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Phase II Trial of High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With Metastatic Malignant Melanoma

Phase 2
18 Years
Open (Enrolling)
Malignant Melanoma

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Trial Information

Phase II Trial of High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With Metastatic Malignant Melanoma

Metastatic malignant melanoma remains a disease with a very poor prognosis and median
survival duration of less than one year. Durable remissions with conventional therapy are
rare and therefore clinical trials remain a primary treatment modality for metastatic
disease. There are 2 currently FDA-approved therapies for metastatic melanoma. Chemotherapy
with single agent parenteral dacarbazine or its oral pro-drug, temozolomide, are capable of
producing responses in 6.5 to 20% of patients. These responses are usually minor to partial
at best and are not durable. Combination with other chemotherapeutic drugs has not been
successful. The immune system also seems to play a role in malignant melanoma. High dose
Interferon therapy is the current standard therapy for the adjuvant treatment of stage IIB,
IIC and III melanoma after surgical resection in which it has shown to result in modest
improvements in disease free survival and overall survival. In metastatic disease, various
immunologic approaches have been employed as well. High dose IL-2 can produce a response
rate of about 10-15% in patients with metastatic melanoma. About 5-10% of responses are
complete and some of these complete responses are durable so that the lucky few patients who
have a durable complete response are for all intents and purposes cured. Attempts to combine
chemotherapy with immunotherapy, although improving response rates, has not impacted
survival as summarized in recent meta-analysis.

Inclusion Criteria:

- Pathologically confirmed metastatic malignant melanoma

- Age > 18 years

- ECOG performance status of 0 or 1

- Patients considered good candidate for conventional high dose IL-2

- No chemotherapy, hormonal therapy, immunotherapy or radiation therapy within 1 month
of entry

- Patients with a history or clinical evidence of brain mets must have completed
radiation therapy or surgical treatment of brain lesions and have no evidence of CNS
progression for at least 8 weeks at the time of enrollment.

- Patients may have had prior high dose IL-2 or temozolomide but not together or with
high dose IL-2 followed by temozolomide

- Patients may have had prior high dose interferon as adjuvant treatment for high risk

- Serum creatinine < 2 mg/dL

- Bilirubin < 2 mg/dL

Exclusion Criteria:

- Inability to provide informed consent

- Hypersensitivity to temozolomide or HD IL-2

- Active gastrointestinal disorder or cardiac disorders

- EF < 50% by echo or corrected DLCO < 50% on diffusion capacity testing PFTs

- PLT < 100K, ANC < 1000

- Serum Cr < 2 x ULN

- Chronic use of steroids other than for simple adrenal replacement

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine clinical response to high dose IL2 followed by low dose temozolomide

Outcome Description:

Accrual of first 12 patients

Outcome Time Frame:

two years

Safety Issue:


Principal Investigator

Joseph J Drabick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Milton S. Hershey Medical Center


United States: Institutional Review Board

Study ID:

PSHCI 09-067



Start Date:

May 2010

Completion Date:

June 2013

Related Keywords:

  • Malignant Melanoma
  • metastatic melanoma
  • Melanoma



Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033