Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
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Purpose
RATIONALE: Denileukin diftitox may be able to make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with metastatic melanoma or metastatic kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer Melanoma (Skin) |
Biological: denileukin diftitox |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer |
- Clinical response [ Designated as safety issue: No ]
- Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Study Start Date: | March 2004 |
OBJECTIVES:
Primary
- Determine the clinical response in patients with metastatic melanoma or metastatic kidney cancer treated with denileukin diftitox.
Secondary
- Determine whether changes occur in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood of these patients before and after treatment with this drug.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: Patients are stratified according to disease type (metastatic melanoma vs metastatic kidney cancer).
Patients receive denileukin diftitox IV over 1 hour on days 1-5, 21-25, 42-46, and 63-67. Treatment repeats every 84 days (12 weeks) for up to a maximum total of 5 courses in the absence of disease progression, autoimmune ocular toxicity attributable to denileukin diftitox, or any other unacceptable toxicity. At any time during therapy, patients achieving a complete response receive 1 additional course of therapy after the complete response.
PROJECTED ACCRUAL: A total of 10-96 patients (5-48 per stratum) will be accrued for this study within 3-4 years.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
- Melanoma
- Kidney cancer
- Metastatic disease
- Measurable disease
- Documented disease progression while receiving standard therapy
- No resectable local or regional disease
PATIENT CHARACTERISTICS:
Age
- 16 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 3 months
Hematopoietic
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 90,000/mm^3
- Lymphocyte count ≥ 500/mm^3
- No concurrent coagulation disorders
Hepatic
- Bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL for patients with Gilbert's syndrome)
- AST and ALT < 3 times normal
- Albumin ≥ 2.5 g/dL
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal
- Creatinine ≤ 2.0 mg/dL
Cardiovascular
- Normal thallium stress test*
- No prior myocardial infarction
- No history of severe coronary artery disease
- No major medical illness of the cardiovascular system NOTE: *For patients > 50 years of age OR who have a history of cardiovascular disease
Pulmonary
- No major medical illness of the respiratory system
Immunologic
- HIV negative
- No active systemic infection
- No presence of opportunistic infections
- No primary or secondary immunodeficiency
- No autoimmune disease
- No other known immunodeficiency
Other
- No sensitivity to denileukin diftitox or any of its components (e.g., diphtheria toxin, interleukin-2, or excipients)
- Willing to undergo leukapheresis
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior treatment with interleukin-2 allowed provided the patient's disease status required this therapy
Chemotherapy
- Recovered from prior chemotherapy
Endocrine therapy
- No concurrent systemic steroids
Radiotherapy
- Recovered from prior radiotherapy
Surgery
- Not specified
Other
- More than 3 weeks since prior systemic anticancer therapy
- No other concurrent systemic anticancer therapy
Contacts and Locations| United States, Maryland | |
| NCI - Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00082914 History of Changes |
| Obsolete Identifiers: | NCT00078702 |
| Other Study ID Numbers: | CDR0000361715, NCI-04-C-0134 |
| Study First Received: | May 14, 2004 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent renal cell cancer stage IV renal cell cancer recurrent melanoma stage IV melanoma |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Melanoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Denileukin diftitox Interleukin-2 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013