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A Phase 2 Trial for Patients With Metastatic Solid Cancer

Primary Purpose

Metastatic Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Keytruda Injectable Product
Yervoy Injectable Product
Cytoxan
Cryosurgical freezing (cryosurgery)
GM-CSF Injectable
Sponsored by
Rampart Health, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be willing and able to provide written informed consent/assent for the trial.
  • Be ≥18 years of age on day of signing informed consent.
  • Have a performance status of 0-3 on the ECOG Performance Scale.
  • Have a life expectancy of 6 months or more as determined by treating physician.
  • Have exhausted all other standard therapies; Have failed available therapy or are not a candidate for, or refuse available therapy (i.e. concerned with high adverse events rate in available therapy or outcome worse than disease); or failure of prior chemotherapy.
  • Histologically-documented solid cancer. All subjects must submit their primary tumor or metastatic pathology specimens and laboratory and imaging reports to Rampart Health where they will be centrally reviewed. Central Rampart Health pathologic review is not required for screening but rather for confirmation of diagnosis and histologic subtype of cancer. Local pathologic review is sufficient for eligibility determination.
  • Measurable disease as defined using iRECIST criteria and identified by radiographic imaging (Imaging should be current within the past three months of subject entering the study; if not repeat imaging must be done prior to enrollment.). In order to be eligible, the patient must have at least one metastatic bone and/or metastatic soft tissue site, lymph node site, and/or bone site with cancer mass measuring 1.0 cm or more in diameter based on soft tissue, lymph node, and/or bone lesions as defined by any of the following:

    • Any soft tissue lesion defined by imaging deemed by the physician to be consistent with distant metastatic disease. For patients undergoing PSMA PET (prostate cancer patients only), only PSMA avid lesions that have a CT or MRI correlate consistent with metastasis will be counted as a site of metastasis.
    • Metastatic lymph node disease defined by imaging. Any lymph node ≥ 1.5 cm in shortest dimension will be noted as involved with disease.
    • Bone metastases defined by bone imaging. If the patient has technetium bone scan and/or NaF PET performed, either study may be used for documenting metastases; both scans do not need to show the number of metastases required for study entry. For patients undergoing PSMA PET (prostate cancer patients only), only PSMA-avid lesions that are consistent with metastasis will be counted as a site of metastasis.
  • The effects of the medications in this protocol on the developing human fetus are unknown. Any subject treated or enrolled on this protocol must agree to use adequate contraception prior to the first dose of study therapy, for the duration of the study participation, and for 120 days after the last dose of study therapy.
  • Their partners will also be encouraged to use proper method of contraception.
  • Acceptable initial laboratory values within 14 days of treatment initiation according to the following:

ANC ≥ 1500/μl Hemoglobin ≥ 9.0 g/dL(prior transfusion permitted) Platelet count ≥ 100,000/μl Creatinine ≤ 2.0 x the institutional upper limit of normal (ULN) OR creatinine clearance >30 ml/min Potassium ≥ 3.5 mmol/L (within institutional normal range) Bilirubin ≤ 1.5 x ULN (unless documented Gilbert's disease) SGOT (AST) ≤ 2.5x ULN, or <5x ULN in patients with documented liver metastases SGPT (ALT) ≤ 2.5x ULN or <5x ULN in patients with documented liver metastases Albumin >2.5 mg/dL Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.

Deviation from these values is allowed at the discretion of the treating investigator.

  • NOTE: Women of child-bearing potential will be tested for pregnancy (which must be negative) before treatment is given. Acceptable range is < 5 mIU/mL
  • No active major medical or psychological problems that could be complicated by study participation.

Exclusion Criteria:

  • Is currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Has bone metastasis as the only site of disease.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of trial treatment, with the exception of steroids for adrenal insufficiency in which case prednisone <10mg/day or its equivalent is allowed.
  • Has a performance status of 4-5 on the ECOG Performance Scale.
  • Has a known history of active TB (Bacillus Tuberculosis).
  • Hypersensitivity to monoclonal antibodies such as nivolumab (or pembrolizumab) or any of its excipients.
  • Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Is taking any current medication known to interfere with serum PSA concentration or radiographic extent of cancer (e.g., Enzalutamide, hormonal therapy) within 30 days for non-depot or 90 days for depot of start of treatment.
  • Clinically significant (i.e. active) cardiovascular disease: cerebral vascular accident (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Persisting toxicity related to prior therapy (NCI CTCAE v.5 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, Grade 2 anemia, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
  • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include carcinoid, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Has a metastatic lesion in locations that is deemed by the investigator as high risk for procedure-related complications (e.g., bleeding, nerve and/or bowel damage) despite consideration of preventative techniques such as hydro-dissection with fluid to push away adjacent crucial structures.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs), including but not limited to systemic or cutaneous lupus erythematosus, cutaneous psoriasis, psoriatic arthritis, rheumatoid arthritis, scleroderma, sicca syndrome, polymyalgia rheumatica, polyarteritis nodosa, granulomatous polyangiitis, microscopic polyangiitis, polyarteritis nodosa, temporal arteritis, giant-cell arteritis, dermatomyositis, Kawasaki disease. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, hydroxychloroquine, etc.) is not considered a form of systemic treatment.
  • Has known recent (within 2 years) history of, or any evidence of active, non-infectious pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorder or any other condition that would interfere with cooperation with the requirements of the trial in the opinion of the Physician-investigator.
  • Pregnant and/or expecting to bear or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed within 30 days.
  • Personal representative (family member or friend) withholds consent for any reason.
  • Unable for any reason to understand the consent form and other written information and freely give written informed consent.
  • Score less than 12.0 (out of possible maximum of 20) on the UBACC Capacity to Consent Assessment Instrument.
  • Hypersensitivity to Cyclophosphamide.
  • Hypersensitivity to GM-CSF.

Sites / Locations

  • Ascension Providence Rochester HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm. Subjects receiving treatment.

Arm Description

Efficacy of Cryosurgical Freezing and Multiplex Immunochemotherapy as determined by overall response rate of radiographic changes according to iRECIST criteria.

Outcomes

Primary Outcome Measures

Primary Endpoint: Efficacy
Efficacy of Cryosurgical Freezing and Multiplex Immunochemotherapy as determined by overall response rate of radiographic changes according to iRECIST criteria.

Secondary Outcome Measures

Efficacy of Cryosurgical Freezing and Multiplex Immunochemotherapy
Efficacy of Cryosurgical Freezing and Multiplex Immunochemotherapy as determined by RECIST1.1 criteria

Full Information

First Posted
January 13, 2021
Last Updated
June 15, 2022
Sponsor
Rampart Health, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT04713371
Brief Title
A Phase 2 Trial for Patients With Metastatic Solid Cancer
Official Title
A Phase 2 Trial of Cryosurgical Freezing and Multiplex Immunochemotherapy in Patients With Metastatic Solid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rampart Health, L.L.C.

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
This study seeks to estimate the potential efficacy of the study treatment, as well as the occurrence of adverse events.
Detailed Description
Cryosurgical freezing (limited to 1.5 cm diameter single freeze within the cancer (up to two cancer sites selected and treated)) will release intact antigens to prime the immune system. The study treatment immunotherapeutic drugs (PD-1 inhibitor monoclonal antibody nivolumab or pembrolizumab and anti-CTLA-4 monoclonal antibody ipilimumab, and low-dose cyclophosphamide) will then be sequentially injected directly into each of the treated cancer sites immediately following cryosurgical freezing. These injections will be performed in combination with collagen (Helitene) to improve drug containment at the site of injection for improved local effect rather than rapid disbursement and dilution throughout adjacent interstitial spaces, as well as sustained drug delivery over time rather than a burst-release pattern. Prior to study treatment, oral low dose cyclophosphamide will be given. Post-treatment, daily subcutaneous low-dose GM-CSF injections will also be administered subsequently. It is speculated that neoantigens released from the cryoablated necrotic cancer will be available in the vicinity of the cryosurgical freezing field immediately following the procedure. Immature dendritic cells attracted to the injection site will internalize neoantigens to become activated to recognize cancer-specific antigenic proteins. The activated dendritic cells will recruit killer T-cells to the injection site to attack cancer cells, and then migrate through the lymphatic system to sites of metastases, targeting cancer-specific neoantigens and recruiting more killer T-lymphocytes to destroy other cancer cells harboring the precise antigenic epitopes (abscopal (bystander) effect). In this way, dendritic cells are capable of initiating cell-mediated systemic immune response in combination with cytotoxic killer T-cells. Regulatory T lymphocytes, which have been implicated in dampening or halting cell-mediated, antigen-specific immune responses, will be selectively depleted by anti-CTLA-4 monoclonal antibodies, low-dose cyclophosphamide, and metronomic GM-CSF. Intra-tumoral injection of the immunotherapeutic medications assists in stimulating and harnessing the local and systemic immune response. GM-CSF prolongs the immune response. Using this combination of therapies, referred to as AbscopalRx5001, it is thought that a clinically significant systemic anti-cancer immune response might be elicited. Intra-tumoral injection of drugs will likely offer fewer side effects than systemic therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Male or female subjects greater than 18 years of age with histologically- proven metastatic cancer with at least one imaging- or histologically- proven metastases to lymph nodes, bone, or soft tissue.
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm. Subjects receiving treatment.
Arm Type
Other
Arm Description
Efficacy of Cryosurgical Freezing and Multiplex Immunochemotherapy as determined by overall response rate of radiographic changes according to iRECIST criteria.
Intervention Type
Drug
Intervention Name(s)
Keytruda Injectable Product
Other Intervention Name(s)
pembrolizumab
Intervention Description
Keytruda (pembrolizumab): PD-1 inhibitor antibody Injectable 50mg/mL, only 2 mL injected.
Intervention Type
Drug
Intervention Name(s)
Yervoy Injectable Product
Other Intervention Name(s)
ipilimumab
Intervention Description
Yervoy (ipilimumab): Anti-CTLA-4 antibody Injectable 5mg/mL, only 2 mL injected.
Intervention Type
Drug
Intervention Name(s)
Cytoxan
Other Intervention Name(s)
Cyclophosphamide
Intervention Description
Injectable 250mg/m2, only 1 mL injected. Oral low dose cyclophosphamide: 50mg once daily pill for 5 days prior to first treatment, 3 days prior to 2nd and 3rd treatment.
Intervention Type
Procedure
Intervention Name(s)
Cryosurgical freezing (cryosurgery)
Other Intervention Name(s)
Cryoablation
Intervention Description
Cryosurgery, also known as cryoablation, for metastatic cancer works by freezing the cancer cells inside the tumor. Cryoablation will release intact antigens to prime the immune system.
Intervention Type
Drug
Intervention Name(s)
GM-CSF Injectable
Other Intervention Name(s)
Sargramostim
Intervention Description
Daily injection administered subcutaneously. 250 mcg daily injections for a total of 25 days post after each treatment.
Primary Outcome Measure Information:
Title
Primary Endpoint: Efficacy
Description
Efficacy of Cryosurgical Freezing and Multiplex Immunochemotherapy as determined by overall response rate of radiographic changes according to iRECIST criteria.
Time Frame
baseline to 8 weeks after end of treatment (approximately 5 months))
Secondary Outcome Measure Information:
Title
Efficacy of Cryosurgical Freezing and Multiplex Immunochemotherapy
Description
Efficacy of Cryosurgical Freezing and Multiplex Immunochemotherapy as determined by RECIST1.1 criteria
Time Frame
baseline to 8 weeks after end of treatment (approximately 5 months);
Other Pre-specified Outcome Measures:
Title
Radiographic progression-free survival (rPFS)
Description
rPFS as determined with both RECISTS1.1 and iRECIST criteria.
Time Frame
baseline to 8 weeks after end of treatment (approximately 5 months);
Title
Best overall response of confirmed PR or CR by independent radiology review
Description
Best overall response of confirmed PR or CR by independent radiology review
Time Frame
baseline to 8 weeks after end of treatment (approximately 5 months)
Title
Time to progression (TTP) based on independent radiology review
Description
Time to cancer progression is measured from the date of first study treatment until the date of cancer progression.
Time Frame
baseline up to 8 weeks after last treatment
Title
Overall survival
Description
Number of participants that are alive.
Time Frame
3 years
Title
Incidence of AEs/SAEs
Description
Incidence of adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time Frame
baseline to 8 weeks after the last treatment
Title
Severity of AEs/SAEs
Description
Severity of AEs/SAEs
Time Frame
baseline through 8 weeks after the last treatment
Title
Duration of AEs/SAEs
Description
Duration of AEs/SAEs
Time Frame
baseline through 8 weeks after the last treatment
Title
The time to objective disease progression
Description
Data will be collected for the design of future studies.
Time Frame
baseline through 8 weeks after the last treatment (Safety Follow-Up)
Title
Endpoint Evaluation
Description
Each of the endpoints will be evaluated after stratifying for site of cancer origin, histologic type, and cancer grade (W.H.O. grading)
Time Frame
Up to 8 weeks after final treatment of last patient enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be willing and able to provide written informed consent/assent for the trial. Be ≥18 years of age on day of signing informed consent. Have a performance status of 0-3 on the ECOG Performance Scale. Have a life expectancy of 6 months or more as determined by treating physician. Have exhausted all other standard therapies; Have failed available therapy or are not a candidate for, or refuse available therapy (i.e. concerned with high adverse events rate in available therapy or outcome worse than disease); or failure of prior chemotherapy. Histologically-documented solid cancer. All subjects must submit their primary tumor or metastatic pathology specimens and laboratory and imaging reports to Rampart Health where they will be centrally reviewed. Central Rampart Health pathologic review is not required for screening but rather for confirmation of diagnosis and histologic subtype of cancer. Local pathologic review is sufficient for eligibility determination. Measurable disease as defined using iRECIST criteria and identified by radiographic imaging (Imaging should be current within the past three months of subject entering the study; if not repeat imaging must be done prior to enrollment.). In order to be eligible, the patient must have at least one metastatic bone and/or metastatic soft tissue site, lymph node site, and/or bone site with cancer mass measuring 1.0 cm or more in diameter based on soft tissue, lymph node, and/or bone lesions as defined by any of the following: Any soft tissue lesion defined by imaging deemed by the physician to be consistent with distant metastatic disease. For patients undergoing PSMA PET (prostate cancer patients only), only PSMA avid lesions that have a CT or MRI correlate consistent with metastasis will be counted as a site of metastasis. Metastatic lymph node disease defined by imaging. Any lymph node ≥ 1.5 cm in shortest dimension will be noted as involved with disease. Bone metastases defined by bone imaging. If the patient has technetium bone scan and/or NaF PET performed, either study may be used for documenting metastases; both scans do not need to show the number of metastases required for study entry. For patients undergoing PSMA PET (prostate cancer patients only), only PSMA-avid lesions that are consistent with metastasis will be counted as a site of metastasis. The effects of the medications in this protocol on the developing human fetus are unknown. Any subject treated or enrolled on this protocol must agree to use adequate contraception prior to the first dose of study therapy, for the duration of the study participation, and for 120 days after the last dose of study therapy. Their partners will also be encouraged to use proper method of contraception. Acceptable initial laboratory values within 14 days of treatment initiation according to the following: ANC ≥ 1500/μl Hemoglobin ≥ 9.0 g/dL(prior transfusion permitted) Platelet count ≥ 100,000/μl Creatinine ≤ 2.0 x the institutional upper limit of normal (ULN) OR creatinine clearance >30 ml/min Potassium ≥ 3.5 mmol/L (within institutional normal range) Bilirubin ≤ 1.5 x ULN (unless documented Gilbert's disease) SGOT (AST) ≤ 2.5x ULN, or <5x ULN in patients with documented liver metastases SGPT (ALT) ≤ 2.5x ULN or <5x ULN in patients with documented liver metastases Albumin >2.5 mg/dL Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. Deviation from these values is allowed at the discretion of the treating investigator. NOTE: Women of child-bearing potential will be tested for pregnancy (which must be negative) before treatment is given. Acceptable range is < 5 mIU/mL No active major medical or psychological problems that could be complicated by study participation. Exclusion Criteria: Is currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. Has bone metastasis as the only site of disease. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of trial treatment, with the exception of steroids for adrenal insufficiency in which case prednisone <10mg/day or its equivalent is allowed. Has a performance status of 4-5 on the ECOG Performance Scale. Has a known history of active TB (Bacillus Tuberculosis). Hypersensitivity to monoclonal antibodies such as nivolumab (or pembrolizumab) or any of its excipients. Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. Is taking any current medication known to interfere with serum PSA concentration or radiographic extent of cancer (e.g., Enzalutamide, hormonal therapy) within 30 days for non-depot or 90 days for depot of start of treatment. Clinically significant (i.e. active) cardiovascular disease: cerebral vascular accident (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Persisting toxicity related to prior therapy (NCI CTCAE v.5 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, Grade 2 anemia, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include carcinoid, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Has a metastatic lesion in locations that is deemed by the investigator as high risk for procedure-related complications (e.g., bleeding, nerve and/or bowel damage) despite consideration of preventative techniques such as hydro-dissection with fluid to push away adjacent crucial structures. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs), including but not limited to systemic or cutaneous lupus erythematosus, cutaneous psoriasis, psoriatic arthritis, rheumatoid arthritis, scleroderma, sicca syndrome, polymyalgia rheumatica, polyarteritis nodosa, granulomatous polyangiitis, microscopic polyangiitis, polyarteritis nodosa, temporal arteritis, giant-cell arteritis, dermatomyositis, Kawasaki disease. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, hydroxychloroquine, etc.) is not considered a form of systemic treatment. Has known recent (within 2 years) history of, or any evidence of active, non-infectious pneumonitis. Has an active infection requiring systemic therapy. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. Has known psychiatric or substance abuse disorder or any other condition that would interfere with cooperation with the requirements of the trial in the opinion of the Physician-investigator. Pregnant and/or expecting to bear or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed within 30 days. Personal representative (family member or friend) withholds consent for any reason. Unable for any reason to understand the consent form and other written information and freely give written informed consent. Score less than 12.0 (out of possible maximum of 20) on the UBACC Capacity to Consent Assessment Instrument. Hypersensitivity to Cyclophosphamide. Hypersensitivity to GM-CSF.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Wilk, M.S.
Phone
804-521-7394
Email
mwilk@ramparthealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Bostwick, M.D., M.B.A.
Organizational Affiliation
Rampart Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ascension Providence Rochester Hospital
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Cribbs
Phone
248-652-5626
Email
Michael.Cribbs@ascension.org

12. IPD Sharing Statement

Learn more about this trial

A Phase 2 Trial for Patients With Metastatic Solid Cancer

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