SJG-136 in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00103220
First received: February 7, 2005
Last updated: December 10, 2013
Last verified: December 2013

February 7, 2005
December 10, 2013
November 2004
February 2007   (final data collection date for primary outcome measure)
Recommended phase 2 dose of SJG-136 [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
Defined as when ≤1 out of 6 patients achieve dose-limiting toxicity (DLT) at highest dose level below the maximally administered dose.
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Complete list of historical versions of study NCT00103220 on ClinicalTrials.gov Archive Site
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SJG-136 in Treating Patients With Advanced Solid Tumors
A Phase I Study With SJG-136 (NSC #694501) in Patients With an Advanced Solid Tumor

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: SJG-136
Given IV
Experimental: Treatment (SJG-136)
Patients receive SJG-136 IV over 20 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: SJG-136
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
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February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00103220
NCI-2012-01462, NCI-2012-01462, MSKCC-04076, CDR0000409581, NCI-6818, 04-076, 6818, U01CA069856
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Naiyer Rizvi Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP