Polyglutamate Camptothecin in Treating Patients With Advanced Cancer

Phase I Study of CT-2106 in Patients With Advanced Malignancy

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.

Study Overview

Detailed Description

OBJECTIVES:

  • 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

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

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

Hepatic

  • 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)

Renal

  • 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

Cardiovascular

  • No significant cardiac disease

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

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

Endocrine therapy

  • Not specified

Radiotherapy

  • 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

Surgery

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

Other

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jakob Dupont, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

May 6, 2003

First Submitted That Met QC Criteria

May 6, 2003

First Posted (Estimate)

May 7, 2003

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

April 1, 2005

More Information

Terms related to this study

Other Study ID Numbers

  • CTI-PGC101
  • MSKCC-03002
  • CDR0000298987 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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