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Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma
This study is ongoing, but not recruiting participants.
First Received: June 2, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005815
  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 melanoma by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness temozolomide plus thalidomide in treating patients who have stage III or stage IV melanoma that cannot be removed during surgery.


Condition Intervention Phase
Intraocular Melanoma
Melanoma (Skin)
Drug: temozolomide
Drug: thalidomide
Phase I
Phase II

Genetics Home Reference related topics: retinoblastoma
MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Thalidomide Temozolomide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I/II Study of Temozolamide and Thalidomide in the Treatment of Advanced Melanoma

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

Study Start Date: December 1999
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose (MTD) of temozolomide using an extended continuous schedule in combination with thalidomide in patients with advanced melanoma.
  • Determine the response rate to this combination using an extended continuous schedule at the MTD in 30 patients who have advanced metastatic melanoma without brain metastases and in 15 patients who have metastatic melanoma in the brain.
  • Further characterize the safety and toxicity of this combination in these patients.

OUTLINE: This is a dose escalation study of temozolomide (phase I) followed by a response rate determination study (phase II).

Patients receive oral temozolomide daily for 6 weeks followed by 2-4 weeks of rest. Patients receive oral thalidomide daily for the entire 8-10 week course. Treatment continues in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Once the MTD is determined, additional patients are accrued to receive treatment with temozolomide and thalidomide at the recommended phase II dose.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for phase I and then an additional 45 patients (15 with CNS disease, 30 without CNS disease) will be accrued for phase II of this study within 18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic malignant melanoma that is considered unresectable

    • Stage III or IV ocular, mucosal, or cutaneous melanoma
  • Measurable disease
  • No CNS disease (phase I only)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 150,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT/SGPT no greater than 3 times ULN
  • Alkaline phosphatase no greater than 3 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No history of active angina
  • No myocardial infarction within past 6 months
  • No history of significant ventricular arrhythmia requiring medication with antiarrhythmics

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 4 weeks before and after study
  • No frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)
  • No preexisting neurotoxicity grade 2 or greater
  • No serious concurrent infections treated with antibiotics
  • No nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study
  • No psychiatric disorders that would preclude study compliance
  • No other medical condition or reason that would preclude study
  • No other malignancy within the past 2 years except:

    • Nonmelanoma skin cancer
    • Carcinoma in situ of the cervix
    • History of T1a or b prostate cancer detected incidentally at TURP and comprising less than 5% of resected tissue with PSA normal since TURP
  • No AIDS related illness
  • HIV negative

PRIOR CONCURRENT THERAPY:

  • Recovered from prior therapy

Biologic therapy:

  • At least 4 weeks since prior biologic therapy
  • At least 4 weeks since prior immunotherapy
  • No concurrent immunotherapy

Chemotherapy:

  • No prior systemic chemotherapy for metastatic melanoma
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery
  • At least 3 weeks since prior radiotherapy to the brain if brain metastases from melanoma
  • Prior radiotherapy to only indicator lesion allowed provided recent evidence of disease progression at that site
  • No concurrent radiotherapy

Surgery:

  • At least 2 weeks since prior surgery requiring general anesthesia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005815

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Wen-Jen Hwu, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067818, MSKCC-99103, NCI-G00-1786
Study First Received: June 2, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005815     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
iris melanoma
ciliary body and choroid melanoma, small size
ciliary body and choroid melanoma, medium/large size
extraocular extension melanoma
recurrent intraocular melanoma
stage III melanoma
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Immunologic Factors
Thalidomide
Eye Neoplasms
Uveal Melanoma
Eye Diseases
Melanoma of the Choroid
Angiogenesis Inhibitors
Immunosuppressive Agents
Temozolomide
Recurrence
Melanoma
Neuroendocrine Tumors
Anti-Bacterial Agents
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Intraocular Melanoma
Neuroepithelioma
Antineoplastic Agents, Alkylating
Nevus
Alkylating Agents

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Thalidomide
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Melanoma
Anti-Bacterial Agents
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas
Angiogenesis Modulating Agents
Growth Inhibitors
Alkylating Agents
Neoplasms by Histologic Type
Eye Neoplasms
Eye Diseases
Growth Substances
Temozolomide
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Antineoplastic Agents, Alkylating
Leprostatic Agents

ClinicalTrials.gov processed this record on May 07, 2009