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

Primary Purpose

Intraocular Melanoma, Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
temozolomide
thalidomide
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraocular Melanoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
June 17, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005815
Brief Title
Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma
Official Title
A Phase I/II Study of Temozolamide and Thalidomide in the Treatment of Advanced Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Type
Drug
Intervention Name(s)
thalidomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Jen Hwu, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12947072
Citation
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.
Results Reference
result
PubMed Identifier
12039921
Citation
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. Erratum In: J Clin Oncol 2002 Aug 1;20(15):3361.
Results Reference
result

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

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