Polyglutamate Camptothecin in Treating Patients With Advanced Cancer

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: NCT00059917
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : May 30, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy such as polyglutamate camptothecin may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged.

PURPOSE: Phase I trial to study the effectiveness of polyglutamate camptothecin in treating patients who have advanced cancer.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: polyglutamate camptothecin Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of polyglutamate camptothecin (CT-2106) in patients with advanced malignancies.
  • Determine the tolerability of this drug in these patients.
  • Determine the safety of this drug in these patients.
  • Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
  • Determine the disease response in patients treated with this drug.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive polyglutamate camptothecin (CT-2106) IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond confirmation of complete response.

Cohorts of 3-6 patients receive escalating doses of CT-2106 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A total of 12-48 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Study of CT-2106 in Patients With Advanced Malignancy
Study Start Date : January 2003
Actual Study Completion Date : May 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed advanced malignancy
  • No active brain metastases (as indicated by clinical symptoms, cerebral edema, or progressive tumor growth) that have been unstable for at least 8 weeks



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present)


  • Creatinine no greater than 1.5 times ULN
  • No history of hemorrhagic cystitis
  • No history of microscopic hematuria associated with drug therapy or radiotherapy or of unknown origin


  • No significant cardiac disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to comply with study schedule and assessments
  • No other significant nonmalignant systemic disease
  • No active infection
  • No other condition that would in the investigator's opinion make the patient an inappropriate study candidate


Biologic therapy

  • Not specified


  • No more than 3 prior chemotherapy regimens
  • More than 4 weeks since prior chemotherapy

Endocrine therapy

  • Not specified


  • More than 4 weeks since prior definitive radiotherapy (except for palliative reasons to sites of nonmeasurable disease, in patients with measurable disease at baseline)
  • Concurrent palliative radiotherapy allowed


  • More than 4 weeks since prior major thoracic or abdominal surgery


  • Recovered from prior therapy (except alopecia or stable grade 1 neuropathy)
  • More than 4 weeks since prior investigational agents
  • No prior myeloablative therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00059917

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Jakob Dupont, MD Memorial Sloan Kettering Cancer Center

Publications of Results:
McNamara MV, Doroshow JH, Dupont J, et al.: Preliminary pharmacokinetics of CT-2106 (polyglutamate camptothecin) in patients with advanced malignancies. [Abstract] J Clin Oncol 22 (Suppl 14): A-2073, 145s, 2004.
Springett GM, Takimoto C, McNamara M, et al.: Phase I study of CT-2106 (polyglutamate camptothecin) in patients with advanced malignancies. [Abstract] J Clin Oncol 22 (Suppl 14): A-3127, 226s, 2004. Identifier: NCT00059917     History of Changes
Other Study ID Numbers: CTI-PGC101
CDR0000298987 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: April 2005

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action