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STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematologic Malignancies and Patients With Solid Tumors

Primary Purpose

Hematological Malignancies, Leukemia, Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STA-5312
Sponsored by
Synta Pharmaceuticals Corp.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematological Malignancies focused on measuring Hematological Malignancies, Leukemia, Lymphoma, Metastatic, Unresectable solid tumors

Eligibility Criteria

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

Inclusion Criteria: Male and female patients 18 years or older with one of the following malignancies: Histologically or cytologically confirmed hematological malignancy (other than Acute Myeloid Leukemia and Myelodysplastic Syndrome) and if treatment is medically indicated, or, Histologically-confirmed non-hematological malignancy that is metastatic or unresectable and for which no standard therapy is available. Patients with CLL, PLL, CML, CTCL, ATL, and Non-Hodgkin's Lymphoma may be entered if they are refractory to or have relapsed following conventional chemotherapy regimens such as alkylating agents (e.g. chlorambucil and cyclophosphamide), anthracycline combinations [e.g. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)], and/or purine analogues (e.g. fludarabine monophosphate and 2-CDA) and are not currently being considered for re-treatment with conventional regimens Patients with CLL and other leukemic malignancies will be staged according to the modified Rai staging criteria [low-risk, intermediate-risk and high risk]. All patients in the high-risk group (Stage III and IV) are eligible. Intermediate risk patients (Stage I and II) with one or more criteria of active disease (such as progressive lymphocytosis, lymphadenopathy, and splenomegaly, weight loss > 10% within 6 months, extreme fatigue, fever and/or night sweats without evidence of infection, etc.) are also eligible ECOG Performance Status of 0-2 Life expectancy of greater than 12 weeks. Patients must have acceptable organ and marrow function at screening and pre-dose visits as defined below unless approved medically by the clinical investigator. Absolute neutrophils count greater than 1,000 cells/ul for patients with hematologic malignancies and ≥1,500 cells/ul for patients with solid tumors Platelets greater than 100,000/ul Hgb greater than 8.5 g/dL Total bilirubin must be <1.5 mg/dL or < 2X upper limit of normal AST (SGOT) < 2.5 times the upper limit of normal ALT (SGPT) < 2.5 times the upper limit of normal Adequate renal function (serum creatinine < 2.0 mg/dL or a calculated creatinine clearance greater than 50 mL/min) Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator. NCI grade 0-1 left ventricular ejection fraction within 30 days of dosing. The effects of STA-5312 on the developing human fetus are unknown. Therefore, women of childbearing potential (defined as women under 50 years of age or history of amenorrhea for < 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Women who are pregnant or lactating. Patients who have had chemotherapy, radiotherapy (except palliative radiation delivered to < 20% of bone marrow), immunotherapy, or corticosteroids ( > 10 mg/day of prednisone or equivalent) within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. The use of nitrosoureas or mitomycin C within 6 weeks prior to study entry. Patients with prior peripheral blood stem cell rescue or bone marrow transplantation. History of primary brain tumors or active brain metastases. (Patients with previously treated brain metastases who are not receiving corticosteroids or anticonvulsants may be considered for enrollment) History of stroke or other significant neurologic limitations within 6 months prior to study enrollment Use of any investigational agents within 4 weeks of study enrollment. History of severe allergic reactions to excipients (e.g. Tween 80) or had hypersensitivity reactions to other chemotherapeutic agents similar in structure to STA-5312. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator. History of active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe medical illness or infection. Grade 2 or higher sensory or motor neuropathy at screening. Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.

Sites / Locations

  • Wilshire Oncology Medical Group
  • Baptist Cancer Institute
  • University of Chicago
  • Tufts New England Medical Center
  • Newark Beth Israel Medical Center
  • Carolinas HealthCare System
  • The West Clinic
  • The Sarah Cannon Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 20, 2004
Last Updated
December 3, 2008
Sponsor
Synta Pharmaceuticals Corp.
search

1. Study Identification

Unique Protocol Identification Number
NCT00088101
Brief Title
STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematologic Malignancies and Patients With Solid Tumors
Official Title
Phase I Trial of STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematological Malignancies and Patients With Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Synta Pharmaceuticals Corp.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the safety, toxicity and patient tolerance of STA-5312 administered intravenously to patients with relapsed or refractory hematological malignancies and patients with solid tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies, Leukemia, Lymphoma, Metastatic or Unresectable Solid Tumors
Keywords
Hematological Malignancies, Leukemia, Lymphoma, Metastatic, Unresectable solid tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
STA-5312

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients 18 years or older with one of the following malignancies: Histologically or cytologically confirmed hematological malignancy (other than Acute Myeloid Leukemia and Myelodysplastic Syndrome) and if treatment is medically indicated, or, Histologically-confirmed non-hematological malignancy that is metastatic or unresectable and for which no standard therapy is available. Patients with CLL, PLL, CML, CTCL, ATL, and Non-Hodgkin's Lymphoma may be entered if they are refractory to or have relapsed following conventional chemotherapy regimens such as alkylating agents (e.g. chlorambucil and cyclophosphamide), anthracycline combinations [e.g. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)], and/or purine analogues (e.g. fludarabine monophosphate and 2-CDA) and are not currently being considered for re-treatment with conventional regimens Patients with CLL and other leukemic malignancies will be staged according to the modified Rai staging criteria [low-risk, intermediate-risk and high risk]. All patients in the high-risk group (Stage III and IV) are eligible. Intermediate risk patients (Stage I and II) with one or more criteria of active disease (such as progressive lymphocytosis, lymphadenopathy, and splenomegaly, weight loss > 10% within 6 months, extreme fatigue, fever and/or night sweats without evidence of infection, etc.) are also eligible ECOG Performance Status of 0-2 Life expectancy of greater than 12 weeks. Patients must have acceptable organ and marrow function at screening and pre-dose visits as defined below unless approved medically by the clinical investigator. Absolute neutrophils count greater than 1,000 cells/ul for patients with hematologic malignancies and ≥1,500 cells/ul for patients with solid tumors Platelets greater than 100,000/ul Hgb greater than 8.5 g/dL Total bilirubin must be <1.5 mg/dL or < 2X upper limit of normal AST (SGOT) < 2.5 times the upper limit of normal ALT (SGPT) < 2.5 times the upper limit of normal Adequate renal function (serum creatinine < 2.0 mg/dL or a calculated creatinine clearance greater than 50 mL/min) Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator. NCI grade 0-1 left ventricular ejection fraction within 30 days of dosing. The effects of STA-5312 on the developing human fetus are unknown. Therefore, women of childbearing potential (defined as women under 50 years of age or history of amenorrhea for < 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Women who are pregnant or lactating. Patients who have had chemotherapy, radiotherapy (except palliative radiation delivered to < 20% of bone marrow), immunotherapy, or corticosteroids ( > 10 mg/day of prednisone or equivalent) within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. The use of nitrosoureas or mitomycin C within 6 weeks prior to study entry. Patients with prior peripheral blood stem cell rescue or bone marrow transplantation. History of primary brain tumors or active brain metastases. (Patients with previously treated brain metastases who are not receiving corticosteroids or anticonvulsants may be considered for enrollment) History of stroke or other significant neurologic limitations within 6 months prior to study enrollment Use of any investigational agents within 4 weeks of study enrollment. History of severe allergic reactions to excipients (e.g. Tween 80) or had hypersensitivity reactions to other chemotherapeutic agents similar in structure to STA-5312. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator. History of active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe medical illness or infection. Grade 2 or higher sensory or motor neuropathy at screening. Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.
Facility Information:
Facility Name
Wilshire Oncology Medical Group
City
Pamona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Tufts New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
Carolinas HealthCare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
The Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

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STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematologic Malignancies and Patients With Solid Tumors

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