Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma

January 5, 2023 updated by: Rush University Medical Center

A Pilot Study Of Hycamtin (Topotecan) And Thalomid (Thalidomide) In Patients With Recurrent Malignant Gliomas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of combining topotecan and thalidomide in treating patients who have recurrent or refractory malignant glioma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine tumor response rate, duration of response, time to disease progression, and overall survival of patients with recurrent or refractory malignant glioma treated with topotecan and thalidomide.
  • Determine safety and tolerance of this regimen in these patients.

OUTLINE: Patients receive topotecan IV continuously on days 1-21 and oral thalidomide daily on days 1-28. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 2 years.

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Phase 2

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Cancer Institute at Rush University Medical 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 to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent or progressive supratentorial glioblastoma or anaplastic astrocytoma
  • Measurable disease by MRI or CT scan
  • No gliomatosis cerebri, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma
  • Concurrent registration for the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) program

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 4,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL

Renal:

  • Creatinine less than 1.6 mg/dL

Other:

  • No other concurrent malignancy except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 methods of effective contraception 1 month prior to, during, and for 1 month after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No more than 2 prior chemotherapy regimens in adjuvant or metastatic setting
  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • Concurrent anticonvulsants allowed

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
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Rush University Medical Center

Investigators

  • Study Chair: Pam G. Khosla, MD, Rush University Medical Center

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 (Actual)

August 1, 2000

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

April 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068544
  • RUSH-G101
  • NCI-V01-1651

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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