Know Cancer

forgot password

A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain

Phase 2
18 Years
Not Enrolling
Recurrent Melanoma, Stage IV Melanoma, Tumors Metastatic to Brain

Thank you

Trial Information

A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain

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

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

- Cystic lesions

- Lesions situated in a previously irradiated area, unless new growth is

- 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

- No concurrent bisphosphonates (e.g., zoledronate)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (defined as complete or partial)

Outcome Description:

90% confidence intervals will be used.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Susan Krown

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

October 2003

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Tumors Metastatic to Brain
  • Melanoma



Cancer and Leukemia Group BChicago, Illinois  60606