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Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma

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ClinicalTrials.gov Identifier: NCT00072163
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : January 17, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II trial is studying how well giving temozolomide together with thalidomide works in treating patients with brain metastases secondary to melanoma. 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

Condition or disease Intervention/treatment Phase
Recurrent Melanoma Stage IV Melanoma Tumors Metastatic to Brain Drug: temozolomide Drug: thalidomide Phase 2

Detailed Description:

OBJECTIVES: Primary I. Determine the objective response rate in patients with brain metastases secondary to melanoma treated with temozolomide and thalidomide.

Secondary I. Determine the toxic effects of and tolerance to this regimen in these patients.

II. Determine the objective response rate in extracranial metastases of patients treated with this regimen.

III. Determine the time to first disease progression (intra- or extracranial) in patients treated with this regimen.

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain
Study Start Date : October 2003
Actual Primary Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Treatment (temozolomide, thalidomide)
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 CR receive 2 additional courses of therapy beyond CR.
Drug: temozolomide
Given orally
Other Names:
  • SCH 52365
  • Temodal
  • Temodar
  • TMZ

Drug: thalidomide
Given orally
Other Names:
  • Kevadon
  • Synovir
  • THAL
  • Thalomid




Primary Outcome Measures :
  1. Response rate (defined as complete or partial) [ Time Frame: Up to 5 years ]
    90% confidence intervals will be used.


Secondary Outcome Measures :
  1. Time to first progression [ Time Frame: Up to 5 years ]
    Kaplan-Meier method will be used.

  2. Overall survival [ Time Frame: Up to 5 years ]
    Kaplan-Meier method will be used.



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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

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic melanoma
  • 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:

        • Bone lesions
        • Leptomeningeal disease
        • Ascites
        • Pleural/pericardial effusion
        • Lymphangitis cutis/pulmonis
        • Abdominal masses that are not confirmed and followed by imaging techniques
        • Cystic lesions
        • Lesions situated in a previously irradiated area, unless new growth is documented
  • Performance status - CTC 0-1
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • AST and ALT no greater than 2.5 times upper limit of normal (ULN)
  • Lactic dehydrogenase no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Creatinine no greater than 2 mg/dL
  • No history of active angina
  • No history of significant ventricular arrhythmia
  • No history of deep vein thrombosis
  • No myocardial infarction within the past 6 months
  • No acute abnormality by EKG
  • No uncontrolled arrhythmia
  • No history of pulmonary embolism
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 1 highly-effective and 1 additional method of contraception for 28 days before, during, and for 4 weeks after study participation
  • No known HIV disease
  • Thyroid-stimulating hormone normal
  • Serum anticonvulsant levels normal (for patients on anticonvulsants)
  • No frequent vomiting and/or any other medical condition (e.g., partial bowel obstruction) that would preclude oral medication intake
  • No preexisting neuropathy greater than grade 1
  • No uncontrolled seizures
  • No other concurrent medical condition that would preclude study participation
  • At least 4 weeks since prior cytokines

    • Biologic agents used as adjuvants, vaccines, and cellular therapies do not require a 4-week washout period
  • No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No more than 1 prior chemotherapy regimen
  • No prior chemotherapy for brain metastases
  • No prior continuous daily temozolomide
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy
  • No concurrent hormonal therapy except steroids and hormones administered for non-disease-related conditions (e.g., insulin for diabetes) or for control of intracranial edema from brain metastases
  • See Disease Characteristics
  • Prior whole brain radiotherapy (WBRT) allowed provided patient has progressive disease in a measurable CNS lesion
  • Prior stereotactic radiotherapy allowed provided patient has progressive disease in a measurable CNS lesion
  • At least 4 weeks since prior WBRT
  • At least 3 weeks since prior stereotactic radiosurgery
  • No concurrent radiotherapy
  • At least 3 weeks since prior surgical resection
  • No concurrent warfarin or heparin products or their derivatives
  • No concurrent antiplatelet therapy (e.g., daily aspirin, ibuprofen, or clopidogrel bisulfate)
  • No concurrent bisphosphonates (e.g., zoledronate)

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): NCT00072163


Locations
United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Susan Krown Cancer and Leukemia Group B

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00072163     History of Changes
Other Study ID Numbers: NCI-2012-02560
CALGB-500102
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000335518 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: November 6, 2003    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Temozolomide
Dacarbazine
Thalidomide
Antineoplastic Agents, Alkylating
Alkylating Agents
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