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

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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

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


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

Drug Information available for: Thalidomide Topotecan hydrochloride Topotecan

Genetic and Rare Diseases Information Center resources: Glioma Glioblastoma Gliosarcoma Brain Tumor, Adult Anaplastic Astrocytoma Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

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

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


United States, Illinois
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, United States, 60612

Sponsors and Collaborators

Rush University Medical Center

Investigators


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

More Information


ClinicalTrials.gov Identifier:	NCT00014443 History of Changes
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:


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 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 Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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