A Phase I Study With SJG-136 (NSC #694501) in Patients With an Advanced Solid Tumor
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Study With SJG-136 (NSC #694501) in Patients With an Advanced Solid Tumor
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 determine preliminary efficacy data and evaluation of correlative markers of DNA
damage and apoptosis in peripheral blood lymphocytes.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive SJG-136 intravenously (IV) over 20 minutes on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts
of 3-6 patients receive escalating doses of SJG-136 until the maximum tolerated dose (MTD)
is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Recommended phase 2 dose of SJG-136
Outcome Description:
Defined as when ≤1 out of 6 patients achieve dose-limiting toxicity (DLT) at highest dose level below the maximally administered dose.
Outcome Time Frame:
Day 28
Safety Issue:
Yes
Principal Investigator
Naiyer Rizvi
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-01462
NCT ID:
NCT00103220
Start Date:
November 2004
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
