|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00072163 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in 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. Combining temozolomide with thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with thalidomide works in treating patients with brain metastases secondary to melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) Metastatic Cancer |
Drug: temozolomide Drug: thalidomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain |
| Study Start Date: | October 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses of therapy beyond CR.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 2 years.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 1.5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinical evidence of brain metastases
At least 1 unidimensionally measurable brain lesion at least 2.0 cm by conventional techniques OR at least 1.0 cm by spiral CT scan or MRI
The following lesions are not considered measurable:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 4 weeks since prior cytokines
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Show 76 Study Locations| Study Chair: | Susan E. Krown, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000335518, CALGB-500102 |
| Study First Received: | November 4, 2003 |
| Last Updated: | August 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00072163 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV melanoma tumors metastatic to brain recurrent melanoma |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Thalidomide Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Melanoma Anti-Bacterial Agents Neoplastic Processes Pathologic Processes Neoplasms, Germ Cell and Embryonal Therapeutic Uses Neoplasm Metastasis Nevi and Melanomas |
Angiogenesis Modulating Agents Growth Inhibitors Alkylating Agents Neoplasms by Histologic Type Growth Substances Temozolomide Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Antineoplastic Agents, Alkylating Leprostatic Agents |