Clinical trial NCT00103220: SJG-136 in Treating Patients With Advanced Solid Tumors
Official title: A Phase I Study With SJG-136 (NSC #694501) in Patients With an Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-02-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 the growth of tumor cells, either by killing the cells or by stopping them from dividing.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recommended phase 2 dose of SJG-136
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Naiyer Rizvi
role: PRINCIPAL_INVESTIGATOR
References: