Biochemotherapy With Temozolomide for Metastatic Melanoma

NCT00505635 | Terminated Phase 2 Results

• 1 other identifier: DM03-0218
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

advanced stage IV melanoma; unresectable stage III melanoma; Melanoma; Temozolomide; Velban; Vinblastine; Cisplatin; Interleukin-2; Intron-A; Interferon Alpha-2b; Thalidomide; Thalomid; Temodar; Proleukin

Outcome Measures

Primary Outcomes (1)

• Time to Progression (TTP)

  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.

  Following two 21 day cycles until disease progression

Secondary Outcomes (1)

• Number of Participants With Response

  Following each 21 day cycles

Study Arms (1)

Biochemotherapy with Temozolomide

EXPERIMENTAL

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; Drug: Velban; Drug: Cisplatin; Drug: Interleukin-2; Drug: Intron-A; Drug: Thalidomide

Interventions

Temozolomide DRUG

250 mg/m\^2 By Mouth Every 4 Hours x 3 Doses On Day 1

Also known as: Temodar

Biochemotherapy with Temozolomide

Velban DRUG

1.5 mg/m\^2 By Vein Over 15-30 Minutes On Days 1-4

Also known as: Vinblastine

Biochemotherapy with Temozolomide

Cisplatin DRUG

20 mg/m\^2 By Vein Over 45-120 Minutes On Days 1-4

Also known as: Platinol-AQ, Platinol, CDDP

Biochemotherapy with Temozolomide

Interleukin-2 DRUG

9 MIU/m\^2 By Vein Over 24 Hours x 4 Doses On Days 1-4

Also known as: Proleukin, IL-2

Biochemotherapy with Temozolomide

Intron-A DRUG

5 mu/m\^2 Subcutaneously (Under the skin) Daily On Days 1-5

Also known as: Interferon Alpha-2b

Biochemotherapy with Temozolomide

Thalidomide DRUG

400 mg By Mouth Daily

Also known as: Thalomid

Biochemotherapy with Temozolomide

Eligibility Criteria

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

You may qualify if:

• Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III melanoma are eligible.
• 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.
• 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.
• 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.
• They should have no significant intercurrent illness such as an active infection, uncontrolled psychiatric illness, hypercalcemia (calcium \> 11 mg), or active GI bleeding.
• 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.

You may not qualify if:

• Patients with brain and/or bone metastases only.
• 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.
• 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.
• 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.
• Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma.
• 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.
• 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.
• Patients with history of deep vein thrombi (DVT) or pulmonary embolism (PE) are excluded.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Melanoma

Interventions

Temozolomide; Vinblastine; Cisplatin; Interleukin-2; aldesleukin; Introns; Thalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles

Results Point of Contact

• Title: Nicholas E. Papadopoulos, MD / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-2921

Study Officials

• Nicholas E. Papadopoulos, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 23, 2007
• Study Start: March 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: September 24, 2020
• Results First Posted: April 18, 2012

Record last verified: 2020-09

Locations

US (1)