MDACC Study Summary DM03-0218

Study Summary
No. DM03-0218:.......Melanoma......Nicholas E. Papadopoulos......Melanoma Medical Oncology

Study Summary Title



Study Summary Number:	DM03-0218

Study Title:	Biochemotherapy with Temozolomide, Velban, Cisplatin, Interleukin-2, Interferon-alpha and Thalidomide for Metastatic Melanoma with Optional Intrathecal Interleukin-2 Treatment

Physician

New Patient Referral



Name:	Nicholas E. Papadopoulos	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Melanoma Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2921 Contact us about clinical trials

General Information



Disease Group:	Melanoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Every three to four weeks.

Treatment Agents:	Cisplatin Interferon Alpha-2B Interleukin-2 Temozolomide Thalidomide Vinblastine Sulfate	Home Care:	CVC maintenance; CBC x2/wk during the introduction and weekly during maintenance. Lytes, Mg, and Creatinine as indicated and replacement treatment. Possible use of hematopoetic growth factors, antibiotics, and transfusion of blood products.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Seven (7) days for the portion of treatment that includes biotherapy.


Description/ Intervention:	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.

Study Objectives / Outcomes

Primary objective: To determine time to progression (TTP).
Secondary objectives: To determine the response rate and survival.
To determine the effectiveness in delaying the appearance of Central Nervous System (CNS) disease.
To evaluate the toxicity and effect on quality of life.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	01/06/2004

Study Type:

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 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 ECOG performance status of 0, 1 or 2 will be eligible. (Appendix B).

4) They should have normal blood counts with a 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 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 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 DVT or PE are excluded.

Links

Registration Number: NCT00505635
Study Information on Clinical Trials Registry (clinicaltrials.gov)