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Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors

Primary Purpose

Solid Tumors, Neuroblastoma, Rhabdomyosarcoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VAL-413
Temozolomide
Sponsored by
Valent Technologies, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors focused on measuring irinotecan, pediatric, solid tumor, neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma, medulloblastoma, recurrent

Eligibility Criteria

1 Year - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients must be 1 year of age to ≤ 30 years of age at the time of study entry.
  2. Patients must have had histologic verification of a solid tumor or CNS tumor at either original diagnosis or relapse.
  3. Measurable or evaluable disease is not required for enrollment on this safety/feasibility study.
  4. Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life or for which irinotecan and/or temozolomide are acceptable therapeutic options based on existing standard of care available.
  5. Karnofsky Performance Status ≥ 50% for patients > 16 years of age and Lansky Performance Status ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
  6. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraception method during and for 30 days after study treatment. (Abstinence is considered an acceptable method of effective contraception.)
  7. Prior treatment with temozolomide, vincristine or irinotecan is allowed, although patients must not have had disease progression while receiving either irinotecan, vincristine or temozolomide.
  8. Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, as described below:

    1. Myelosuppressive chemotherapy: patients must not have received myelosuppressive chemotherapy within 21 days of first study treatment, but nitrosourea within 8 weeks (42 days) of first study treatment
    2. Anti-cancer agents not known to be myelosuppressive (e.g., not associated with drops in platelet or neutrophil count): must not have received these therapies within 7 days of first study treatment, or at least 5 half-lives of the agent (whichever is longer)
    3. Antibody therapy: At least 4 weeks must have elapsed since last antibody dose prior to first study treatment
    4. Radiation therapy: At least two weeks must have elapsed since last local palliative radiation (small port) prior to first study treatment. At least 6 weeks must have elapsed if more substantial radiation was administered (e.g., >50% pelvis, craniospinal, whole body), or therapeutic radiolabeled 131I MIBG or other radiopharmaceutical therapy.
    5. High-Dose Chemotherapy with Autologous Stem Cell Transplant/Rescue: At least two months must have elapsed since receiving autologous hematopoietic stem cells prior to first study treatment. Patients who have had allogeneic transplants are ineligible.
    6. Hematopoietic growth factors: must not have been received in the 14 days prior to first study treatment for a long-acting growth factor (e.g., pegfilgrastim), or 7 days prior to first study treatment for short-acting growth factor.
  9. Peripheral absolute neutrophil count (ANC) ≥ 1,000/µL
  10. Platelet count ≥100,000/µL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to first study treatment)
  11. Hemoglobin ≥ 8.0 gm/dL (may receive RBC transfusions) NOTE: Patients with metastatic tumor in the bone marrow ARE eligible provided the above hematologic criteria are met.
  12. Creatinine clearance or radioisotope GFR ≥ 70mL/min/1.73 m2 or Serum creatinine based on age/gender as follows:

    Age Maximum Serum Creatinine (mg/dL) Male Female 1 to < 2 years 0.6 0.6 2 to < 6 years 0.8 0.8 6 to < 10 years 1 1 10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4

    ≥ 16 years 1.7 1.4

    The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC.

  13. Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age
  14. SGPT (ALT) ≤ 5 x upper limit of normal (ULN) for age
  15. Serum albumin ≥ 2 g/dL

Exclusion Criteria:

  1. Patients with a history of severe allergic reaction (e.g., more than simple rash) to dacarbazine or third-generation cephalosporins are ineligible.
  2. Pregnant or breast-feeding women will not be entered on this study due to potential risks of fetal and teratogenic adverse events. A pregnancy test must be obtained prior to starting chemotherapy in post-menarchal female patients.
  3. Patients who are currently receiving investigational drugs, or who have received an investigational drug within the last 7 days prior to first study treatment, are ineligible.
  4. Patients who are currently receiving other anti-cancer agents are ineligible.
  5. Patients taking strong inducers of CYP3A4, including but not limited to phenobarbital, phenytoin, carbamazepine, oxcarbazepine (Trileptal), rifampin, voriconazole, itraconazole, ketoconazole or other systemically-administered azole antifungal drugs, aprepitant (Emend) or St. John's Wort, in the 2 weeks prior to first study treatment are ineligible.
  6. Patients taking strong inhibitors of CYP3A4 or UGT1A1 in the 1 week prior to first study treatment are ineligible.
  7. Patients must not be receiving medications known to inhibit platelet function or known to selectively inhibit cyclooxygenase activity. Medicines in this class are excluded, with the exception of acetaminophen.
  8. Patients who have uncontrolled infections, require IV antibiotics at time of enrollment, or who are currently receiving treatment for Clostridium difficile infection are excluded.
  9. Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.

Sites / Locations

  • UCSF, Mission Bay - Benioff Children's HospitalRecruiting
  • Children's National Research Institute - Children's National HospitalRecruiting
  • University of North Carolina at Chapel Hill - North Carolina Cancer HospitalRecruiting
  • Atrium Health Levine Children's Hospital - Carolinas Medical CenterRecruiting
  • Duke University Children's Hospital and Health CenterRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Sarah Cannon Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

90 mg/m2/day VAL-413 (Orotecan®)

110 mg/m2/day VAL-413 (Orotecan®)

75 mg/m2/day VAL-413 (Orotecan®)

Arm Description

Orotecan® at 90 mg/m2/day administered with Temozolomide at 100 mg/m2/day orally for 5 consecutive days at the beginning of every 21-day cycle. A single dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO) will be substituted at the same dosage as Orotecan® for during Cycle 1.

Orotecan® at 110 mg/m2/day administered with Temozolomide at 100 mg/m2/day orally for 5 consecutive days at the beginning of every 21-day cycle. A single dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO) will be substituted at the same dosage as Orotecan® for during Cycle 1.

In the event the 90 mg/m2/day starting dose is not tolerable due to toxicity, a lower starting dose of 75 mg/m2/day may be implemented. Orotecan® at 75 mg/m2/day administered with Temozolomide at 100 mg/m2/day orally for 5 consecutive days at the beginning of every 21-day cycle. A single dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO) will be substituted at the same dosage as Orotecan® for during Cycle 1.

Outcomes

Primary Outcome Measures

Recommended Phase II Dose (RP2D)
To establish the recommended Phase II dose of a flavored preparation of orally administered irinotecan VAL-413 (Orotecan®) when given in combination with temozolomide for 5 consecutive days

Secondary Outcome Measures

Cmax
Maximum observed concentration of VAL-413 (Orotecan®) on Day 1
Tmax
Time of observed VAL-413 (Orotecan®) Cmax on Day 1
AUClast
Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable VAL-413 (Orotecan®) concentration on Day 1
AUCinf
Area under the concentration-time curve for VAL-413 (Orotecan®) extrapolated to infinity on Day 1
CL/F
Total oral body clearance at steady state calculated as VAL-413 (Orotecan®) dose/AUC on Day 1
MRT
Mean Residence Time for VAL-413 (Orotecan®) calculated as AUMC/AUC where AUMC is Area under the Moment Curve
Vz
The apparent volume of distribution for VAL-413 (Orotecan®) during the terminal phase
Lambda z
The terminal elimination rate constant determined by selection of at least three decreasing data points on the terminal phase of the concentration time curve for VAL-413 (Orotecan®) on Day 1
T1/2
Terminal elimination half-life of VAL-413 (Orotecan®) on Day 1 determined from 0.693/Lambda z
Palatability
To evaluate the palatability of VAL-413 (Orotecan®) using a proprietary Valent Taste Survey which allows pediatric patients or their parents to rate how agreeable they find the flavor of VAL-413 (Orotecan®), on scale from 7, Like Very Much down to 1, Dislike Very Much
Adverse Events
To assess the toxicity profile of this combination therapy using NCI CTCAE guidelines
Treatment Response
To assess treatment response using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline, or for patients with neuroblastoma, the International Neuroblastoma Response Criteria (INRC) guideline

Full Information

First Posted
March 30, 2020
Last Updated
August 10, 2023
Sponsor
Valent Technologies, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04337177
Brief Title
Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors
Official Title
Pilot Pharmacokinetic Study of VAL-413 (Orotecan®) in Patients With Recurrent Pediatric Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valent Technologies, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A pilot pharmacokinetic trial to determine the safety and efficacy of a flavored, orally administered irinotecan VAL-413 (Orotecan®) given with temozolomide for treatment of recurrent pediatric solid tumors including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma
Detailed Description
Up to 20 patients ≥ 1 year of age or ≤ 30 years of age with recurrent pediatric solid tumors will be enrolled. During the first cycle of treatment, each patient will receive 4 daily doses of VAL-413 (Orotecan®) and one daily dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO), together with 5 days of concurrent temozolomide. During all subsequent cycles, only Orotecan® will be given with temozolomide in 5 day courses administered every 21 days as tolerated. The dosing regimen in this study will be Temozolomide at 100 mg/m2/day with Orotecan® at either 90 or 110mg/m2/day, administered orally for 5 consecutive days at the beginning of every 21-day cycle. A single dose of IRN-IVPO will be substituted at the same dosage as Orotecan® during Cycle 1. Up to 17 cycles of treatment may be administered on this study. Data collected from this study will allow for an assessment of Orotecan® safety and efficacy. Interval medical histories, targeted physical exams, complete blood counts, and other laboratory and safety assessments will be performed at Day 1 of each treatment cycle for all study subjects. At baseline and during study, disease status will be assessed by appropriate clinical and imaging evaluation (CT, MRI, or PET) and using Response Evaluation Criteria in Solid Tumors (RECIST), or for patients with neuroblastoma, using International Neuroblastoma Response Criteria. In addition, a palatability survey will be conducted on Day 1 or Day 4 of the first cycle, which will allow patients to evaluate the taste of Orotecan®. Serum samples will be collected at various time points on Days 1 and 4 during Cycle 1 to characterize and compare the pharmacokinetic profiles of Orotecan® and conventional irinotecan given orally. Assessment of first-cycle toxicity will be used to identify the recommended phase II dose for Orotecan®. Toxicity will be evaluated and documented using NCI CTCAE guidelines. The recommended Phase II dose will be identified as the highest dose at which no more than 1 of 6 patients experiences a first cycle dose limiting toxicity (DLT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma, Hepatoblastoma, Medulloblastoma
Keywords
irinotecan, pediatric, solid tumor, neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma, medulloblastoma, recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Two different dose levels of VAL-413 (Orotecan®) will be studied in combination with fixed-dose temozolomide using a standard 3 + 3 phase I design. The first three patients will receive temozolomide in combination with Orotecan® at 90 mg/m2/day, which is the standard dose of irinotecan. If no dose-limiting toxicity (DLT) occurs during Cycle 1 in these patients, then subsequent patients will start Cycle 1 using a Orotecan® dose of 110 mg/m2/day. In the event the starting dose of 90 mg/m2/day is not tolerable due to toxicity, a lower starting dose of 75 mg/m2/day may be implemented.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
90 mg/m2/day VAL-413 (Orotecan®)
Arm Type
Experimental
Arm Description
Orotecan® at 90 mg/m2/day administered with Temozolomide at 100 mg/m2/day orally for 5 consecutive days at the beginning of every 21-day cycle. A single dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO) will be substituted at the same dosage as Orotecan® for during Cycle 1.
Arm Title
110 mg/m2/day VAL-413 (Orotecan®)
Arm Type
Experimental
Arm Description
Orotecan® at 110 mg/m2/day administered with Temozolomide at 100 mg/m2/day orally for 5 consecutive days at the beginning of every 21-day cycle. A single dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO) will be substituted at the same dosage as Orotecan® for during Cycle 1.
Arm Title
75 mg/m2/day VAL-413 (Orotecan®)
Arm Type
Experimental
Arm Description
In the event the 90 mg/m2/day starting dose is not tolerable due to toxicity, a lower starting dose of 75 mg/m2/day may be implemented. Orotecan® at 75 mg/m2/day administered with Temozolomide at 100 mg/m2/day orally for 5 consecutive days at the beginning of every 21-day cycle. A single dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO) will be substituted at the same dosage as Orotecan® for during Cycle 1.
Intervention Type
Drug
Intervention Name(s)
VAL-413
Other Intervention Name(s)
Orotecan®
Intervention Description
a flavored preparation of orally administered irinotecan
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
Temodar, Temodal, Temcad, TMZ
Intervention Description
alkylating oral chemotherapy agent used to treatment brain cancers
Primary Outcome Measure Information:
Title
Recommended Phase II Dose (RP2D)
Description
To establish the recommended Phase II dose of a flavored preparation of orally administered irinotecan VAL-413 (Orotecan®) when given in combination with temozolomide for 5 consecutive days
Time Frame
17 months
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum observed concentration of VAL-413 (Orotecan®) on Day 1
Time Frame
1 day
Title
Tmax
Description
Time of observed VAL-413 (Orotecan®) Cmax on Day 1
Time Frame
1 day
Title
AUClast
Description
Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable VAL-413 (Orotecan®) concentration on Day 1
Time Frame
1 day
Title
AUCinf
Description
Area under the concentration-time curve for VAL-413 (Orotecan®) extrapolated to infinity on Day 1
Time Frame
1 day
Title
CL/F
Description
Total oral body clearance at steady state calculated as VAL-413 (Orotecan®) dose/AUC on Day 1
Time Frame
1 day
Title
MRT
Description
Mean Residence Time for VAL-413 (Orotecan®) calculated as AUMC/AUC where AUMC is Area under the Moment Curve
Time Frame
1 day
Title
Vz
Description
The apparent volume of distribution for VAL-413 (Orotecan®) during the terminal phase
Time Frame
1 day
Title
Lambda z
Description
The terminal elimination rate constant determined by selection of at least three decreasing data points on the terminal phase of the concentration time curve for VAL-413 (Orotecan®) on Day 1
Time Frame
1 day
Title
T1/2
Description
Terminal elimination half-life of VAL-413 (Orotecan®) on Day 1 determined from 0.693/Lambda z
Time Frame
1 day
Title
Palatability
Description
To evaluate the palatability of VAL-413 (Orotecan®) using a proprietary Valent Taste Survey which allows pediatric patients or their parents to rate how agreeable they find the flavor of VAL-413 (Orotecan®), on scale from 7, Like Very Much down to 1, Dislike Very Much
Time Frame
1 month
Title
Adverse Events
Description
To assess the toxicity profile of this combination therapy using NCI CTCAE guidelines
Time Frame
17 months
Title
Treatment Response
Description
To assess treatment response using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline, or for patients with neuroblastoma, the International Neuroblastoma Response Criteria (INRC) guideline
Time Frame
17 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be 1 year of age to ≤ 30 years of age at the time of study entry. Patients must have had histologic verification of a solid tumor or CNS tumor at either original diagnosis or relapse. Measurable or evaluable disease is not required for enrollment on this safety/feasibility study. Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life or for which irinotecan and/or temozolomide are acceptable therapeutic options based on existing standard of care available. Karnofsky Performance Status ≥ 50% for patients > 16 years of age and Lansky Performance Status ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraception method during and for 30 days after study treatment. (Abstinence is considered an acceptable method of effective contraception.) Prior treatment with temozolomide, vincristine or irinotecan is allowed, although patients must not have had disease progression while receiving either irinotecan, vincristine or temozolomide. Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, as described below: Myelosuppressive chemotherapy: patients must not have received myelosuppressive chemotherapy within 21 days of first study treatment, but nitrosourea within 8 weeks (42 days) of first study treatment Anti-cancer agents not known to be myelosuppressive (e.g., not associated with drops in platelet or neutrophil count): must not have received these therapies within 7 days of first study treatment, or at least 5 half-lives of the agent (whichever is longer) Antibody therapy: At least 4 weeks must have elapsed since last antibody dose prior to first study treatment Radiation therapy: At least two weeks must have elapsed since last local palliative radiation (small port) prior to first study treatment. At least 6 weeks must have elapsed if more substantial radiation was administered (e.g., >50% pelvis, craniospinal, whole body), or therapeutic radiolabeled 131I MIBG or other radiopharmaceutical therapy. High-Dose Chemotherapy with Autologous Stem Cell Transplant/Rescue: At least two months must have elapsed since receiving autologous hematopoietic stem cells prior to first study treatment. Patients who have had allogeneic transplants are ineligible. Hematopoietic growth factors: must not have been received in the 14 days prior to first study treatment for a long-acting growth factor (e.g., pegfilgrastim), or 7 days prior to first study treatment for short-acting growth factor. Peripheral absolute neutrophil count (ANC) ≥ 1,000/µL Platelet count ≥100,000/µL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to first study treatment) Hemoglobin ≥ 8.0 gm/dL (may receive RBC transfusions) NOTE: Patients with metastatic tumor in the bone marrow ARE eligible provided the above hematologic criteria are met. Creatinine clearance or radioisotope GFR ≥ 70mL/min/1.73 m2 or Serum creatinine based on age/gender as follows: Age Maximum Serum Creatinine (mg/dL) Male Female 1 to < 2 years 0.6 0.6 2 to < 6 years 0.8 0.8 6 to < 10 years 1 1 10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4 ≥ 16 years 1.7 1.4 The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC. Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age SGPT (ALT) ≤ 5 x upper limit of normal (ULN) for age Serum albumin ≥ 2 g/dL Exclusion Criteria: Patients with a history of severe allergic reaction (e.g., more than simple rash) to dacarbazine or third-generation cephalosporins are ineligible. Pregnant or breast-feeding women will not be entered on this study due to potential risks of fetal and teratogenic adverse events. A pregnancy test must be obtained prior to starting chemotherapy in post-menarchal female patients. Patients who are currently receiving investigational drugs, or who have received an investigational drug within the last 7 days prior to first study treatment, are ineligible. Patients who are currently receiving other anti-cancer agents are ineligible. Patients taking strong inducers of CYP3A4, including but not limited to phenobarbital, phenytoin, carbamazepine, oxcarbazepine (Trileptal), rifampin, voriconazole, itraconazole, ketoconazole or other systemically-administered azole antifungal drugs, aprepitant (Emend) or St. John's Wort, in the 2 weeks prior to first study treatment are ineligible. Patients taking strong inhibitors of CYP3A4 or UGT1A1 in the 1 week prior to first study treatment are ineligible. Patients must not be receiving medications known to inhibit platelet function or known to selectively inhibit cyclooxygenase activity. Medicines in this class are excluded, with the exception of acetaminophen. Patients who have uncontrolled infections, require IV antibiotics at time of enrollment, or who are currently receiving treatment for Clostridium difficile infection are excluded. Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neil Sankar, M.D.
Phone
(408) 215-1578
Email
nsankar@valenttech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lorena Lopez, B.S.
Phone
(925) 292-8360
Email
llopez@solsentinel.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Wagner, M.D.
Organizational Affiliation
Duke University Children's Hospital & Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Geller, M.D.
Organizational Affiliation
Cincinnati Children's Hospital Medical Center (CCHMC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meghann McManus, D.O.
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier Oesterheld, M.D.
Organizational Affiliation
Atrium Health Levine Children's Hospital - Carolinas Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick Thompson, M.D.
Organizational Affiliation
UNC Chapel Hill - North Carolina Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aerang Kim, M.D.
Organizational Affiliation
Children's National Hospital - Washington, DC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kieuhoa Vo, M.D.
Organizational Affiliation
UCSF - Mission Bay
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF, Mission Bay - Benioff Children's Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Fu
Phone
415-290-7129
Email
Lucy.Fu@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Rachel Carney
Phone
(415) 476-3982
Email
rachel.carney@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Kieuhoa Vo, M.D.
Facility Name
Children's National Research Institute - Children's National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Reed
Phone
202-476-3745
Email
rreed@childrensnational.org
First Name & Middle Initial & Last Name & Degree
Ann Liew
Email
aliew@childrensnational.org
First Name & Middle Initial & Last Name & Degree
Aerang Kim, M.D.
Facility Name
University of North Carolina at Chapel Hill - North Carolina Cancer Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juanita Cuffee
Phone
919-966-0017
Email
juanita_cuffee@med.unc.edu
First Name & Middle Initial & Last Name & Degree
D'Amani Hillman
Phone
(919) 962-3530
Email
Damani_hillman@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Patrick Thompson, M.D.
Facility Name
Atrium Health Levine Children's Hospital - Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurelie May, R.N.
Email
aurelie.may@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Tracy Fukes
Email
Tracy.Fukes@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Javier Oesterheld, M.D.
Facility Name
Duke University Children's Hospital and Health Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Sedito, BSN, RN
Phone
919-668-6432
Email
diana.sedito@duke.edu
First Name & Middle Initial & Last Name & Degree
Patrick Barrera
Phone
(919) 613-1895
Email
patrick.barrera@duke.edu
First Name & Middle Initial & Last Name & Degree
Lars Wagner, M.D.
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Backus
Phone
513-636-2047
Email
Lori.Backus@cchmc.org
First Name & Middle Initial & Last Name & Degree
James Geller, M.D.
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Channing Dudley, MSN, RN, FNP
Phone
615-340-2915
Email
Channing.Dudley@SarahCannon.com
First Name & Middle Initial & Last Name & Degree
Cheryl Edens
Phone
(615) 329-6885
Email
Cheryl.Edens@sarahcannon.com
First Name & Middle Initial & Last Name & Degree
Meghann McManus, D.O.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors

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