Status:
COMPLETED
STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematologic Malignancies and Patients With Solid Tumors
Lead Sponsor:
Synta Pharmaceuticals Corp.
Conditions:
Hematological Malignancies
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00088101
Start Date
February 1 2004
End Date
December 1 2004
Last Update
December 4 2008
Active Locations (8)
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1
Wilshire Oncology Medical Group
Pomona, California, United States, 91767
2
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
3
University of Chicago
Chicago, Illinois, United States, 60637
4
Tufts New England Medical Center
Boston, Massachusetts, United States, 02111