COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Biochemotherapy With Temozolomide for Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00505635
Recruitment Status : Terminated (Slow accrual)
First Posted : July 23, 2007
Results First Posted : April 18, 2012
Last Update Posted : June 17, 2016
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if treatment with Temodar (temozolomide), Velban (vinblastine), Cisplatin, Proleukin (interleukin-2), Intron-A (interferon alpha), and thalidomide can help to control melanoma that has spread to other parts of the body. The safety of this treatment will also be studied.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Temozolomide Drug: Velban Drug: Cisplatin Drug: Interleukin-2 Drug: Intron-A Drug: Thalidomide Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biochemotherapy With Temozolomide, Velban, Cisplatin, Interleukin-2, Interferon-alpha and Thalidomide for Metastatic Melanoma With Optional Intrathecal Interleukin-2 Treatment
Study Start Date : March 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Biochemotherapy with Temozolomide
Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
Drug: Temozolomide
250 mg/m^2 By Mouth Every 4 Hours x 3 Doses On Day 1
Other Name: Temodar

Drug: Velban
1.5 mg/m^2 By Vein Over 15-30 Minutes On Days 1-4
Other Name: Vinblastine

Drug: Cisplatin
20 mg/m^2 By Vein Over 45-120 Minutes On Days 1-4
Other Names:
  • Platinol-AQ
  • Platinol
  • CDDP

Drug: Interleukin-2
9 MIU/m^2 By Vein Over 24 Hours x 4 Doses On Days 1-4
Other Names:
  • Proleukin
  • IL-2

Drug: Intron-A
5 mu/m^2 Subcutaneously (Under the skin) Daily On Days 1-5
Other Name: Interferon Alpha-2b

Drug: Thalidomide
400 mg By Mouth Daily
Other Name: Thalomid

Primary Outcome Measures :
  1. Time to Progression (TTP) [ Time Frame: Following two 21 day cycles until disease progression ]
    TTP defined as the time from date of first dose of study medication to first documentation of objective tumor progression in days. Response evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) done following 2 cycles and 3 cycles. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.

Secondary Outcome Measures :
  1. Number of Participants With Response [ Time Frame: Following each 21 day cycles ]
    Response evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III melanoma are eligible.
  2. They should have recurrent melanoma with measureable or evaluable sites of disease in order to assess the response to treatment by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
  3. Patients between 18 years of age and 65 years of age with an expected survival greater than 8 weeks and a Karnofsky performance status of 50% or better or an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 will be eligible.
  4. They should have normal blood counts with a white blood count (WBC) count of more than or equal to 3000/mm^3 an absolute neutrophil count of more than or equal to 1500/mm^3 and a platelet count of more than 100,000/mm^3 and have no impairment of renal function (serum creatinine of less than 1.6 mg/dl), hepatic function (serum bilirubin level of < 1.2 mg/dl) and no evidence of significant cardiac or pulmonary dysfunction.
  5. They should have no significant intercurrent illness such as an active infection, uncontrolled psychiatric illness, hypercalcemia (calcium > 11 mg), or active GI bleeding.
  6. They should not have been exposed to any previous chemotherapy or isolation perfusion for malignant melanoma and have had no previous exposure to interleukin-2. Prior adjuvant interferon is permitted. Prior radiation therapy for metastatic melanoma is permitted provided the patient has un-irradiated metastatic sites for response evaluation and has fully recovered from its toxicity.

Exclusion Criteria:

  1. Patients with brain and/or bone metastases only.
  2. Patients with symptomatic central nervous system involvement by melanoma either as brain metastasis by MRI or spinal cord compression. Patients with brain metastases are not eligible unless their disease can be resected, it is asymptomatic, not associated with cerebral edema, or they are clinically stable after radiation and off corticosteroid therapy for 4 weeks. No major surgery or RT within 21 days before starting of treatment.
  3. Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (EF <55%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy. Patients with an electrocardiogram (EKG) disclosing an absolute QT interval >460 msec in the presence of serum potassium >/=4.0 mEq/L and magnesium >/= 1.8 mg/dL. Patients with heart rate less than 50.
  4. Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of Left Ventricular Ejection Fraction (FE VI) to <75% of predicted normal values.
  5. Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma.
  6. Patients who are unable to stay in Houston to receive therapy (first cycle) and be able to return for follow-up visits as required by this study.
  7. Patients with a history of second malignant tumor, other than the common skin cancers - basal and squamous carcinomas, within the past 5 years and uncertainty about the histological nature of the metastatic lesions.
  8. Patients with history of deep vein thrombi (DVT) or pulmonary embolism (PE) are excluded.

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 identifier (NCT number): NCT00505635

Layout table for location information
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Layout table for investigator information
Principal Investigator: Nicholas E. Papadopoulos, MD M.D. Anderson Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00505635    
Other Study ID Numbers: DM03-0218
First Posted: July 23, 2007    Key Record Dates
Results First Posted: April 18, 2012
Last Update Posted: June 17, 2016
Last Verified: March 2012
Keywords provided by M.D. Anderson Cancer Center:
advanced stage IV melanoma
unresectable stage III melanoma
Interferon Alpha-2b
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Immunosuppressive Agents
Leprostatic Agents