Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma

NCT00005815 | Completed Phase 1

• 3 other identifiers: 99-103CDR0000067818NCI-G00-1786
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Intraocular Melanoma; Melanoma (Skin)

Keywords

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

Interventions

temozolomide DRUG

thalidomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (2)

• Hwu WJ, Krown SE, Menell JH, Panageas KS, Merrell J, Lamb LA, Williams LJ, Quinn CJ, Foster T, Chapman PB, Livingston PO, Wolchok JD, Houghton AN. Phase II study of temozolomide plus thalidomide for the treatment of metastatic melanoma. J Clin Oncol. 2003 Sep 1;21(17):3351-6. doi: 10.1200/JCO.2003.02.061.

  PMID: 12947072 RESULT

• Hwu WJ, Krown SE, Panageas KS, Menell JH, Chapman PB, Livingston PO, Williams LJ, Quinn CJ, Houghton AN. Temozolomide plus thalidomide in patients with advanced melanoma: results of a dose-finding trial. J Clin Oncol. 2002 Jun 1;20(11):2610-5. doi: 10.1200/JCO.2002.09.034.

  PMID: 12039921 RESULT

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

Temozolomide; Thalidomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Wen-Jen Hwu, MD, PhD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: January 27, 2003
• Study Start: December 1, 1999
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)