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

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.
 
ClinicalTrials.gov Identifier: NCT00014443
Recruitment Status : Unknown
Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : July 24, 2008
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: thalidomide Drug: topotecan hydrochloride Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Primary Purpose: Treatment
Official Title: A Pilot Study Of Hycamtin (Topotecan) And Thalomid (Thalidomide) In Patients With Recurrent Malignant Gliomas
Study Start Date : August 2000

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00014443


Locations
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United States, Illinois
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Study Chair: Pam G. Khosla, MD Rush University Medical Center
More Information
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ClinicalTrials.gov Identifier: NCT00014443    
Other Study ID Numbers: CDR0000068544
RUSH-G101
NCI-V01-1651
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: January 2006
Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Thalidomide
Topotecan
Topoisomerase I Inhibitors
 Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors