SJG-136 in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00103220
Recruitment Status : Completed
First Posted : February 8, 2005
Last Update Posted : December 11, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

February 7, 2005
February 8, 2005
December 11, 2013
November 2004
February 2007   (Final data collection date for primary outcome measure)
Recommended phase 2 dose of SJG-136 [ Time Frame: Day 28 ]
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 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.


I. To determine the toxicities, pharmacokinetic profile and the recommended phase 2 dose of SJG-136 in patients with an advanced solid tumor.


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.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
NCI-2012-01462 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
04-076 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
6818 ( Other Identifier: CTEP )
U01CA069856 ( U.S. NIH Grant/Contract )
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National Cancer Institute (NCI)
National Cancer Institute (NCI)
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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