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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00014443

First received: April 10, 2001

Last updated: July 23, 2008

Last verified: January 2006

History of Changes

Purpose

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	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: thalidomide Drug: topotecan hydrochloride	Phase 1


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Pilot Study Of Hycamtin (Topotecan) And Thalomid (Thalidomide) In Patients With Recurrent Malignant Gliomas

Resource links provided by NLM:

Drug Information available for: Thalidomide Topotecan hydrochloride Topotecan

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

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):


Estimated Enrollment:	20
Study Start Date:	August 2000

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	April 10, 2001
Last Updated:	July 23, 2008

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

ClinicalTrials.gov processed this record on July 19, 2017

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