Status:
COMPLETED
SJG-136 in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop th...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the toxicities, pharmacokinetic profile and the recommended phase 2 dose of SJG-136 in patients with an advanced solid tumor. SECONDARY OBJECTIVES: I. To determi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed solid tumor
- Advanced disease, defined as metastatic or unresectable disease
- Measurable indicator lesions
- Standard curative or palliative measures do not exist or are no longer effective
- Previously treated CNS metastases allowed provided patient has completed local therapy AND corticosteroids have been discontinued for at least 4 weeks
- No known leptomeningeal metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 3 months
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin ≤ 1.0 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine \< 1.4 mg/dL
- No congestive heart failure
- No recent myocardial infarction
- No unstable angina
- No uncontrolled hypertension
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug
- No other significant medical history, unstable medical condition, or unstable systemic disease that would preclude study participation
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas and 8 weeks for UCN-01)
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to ≥ 25% of hematopoietic bone marrow
- Recovered from all prior therapy
- At least 4 weeks since prior investigational anticancer drugs
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00103220
Start Date
November 1 2004
Last Update
December 11 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065