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Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer

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ClinicalTrials.gov Identifier: NCT01355562
Recruitment Status : Withdrawn (Primary Investigator is no longer employed at LLU as of 02/29/12.)
First Posted : May 18, 2011
Last Update Posted : October 5, 2012
Sponsor:
Information provided by (Responsible Party):
Chien-Shing Chen, Loma Linda University

Brief Summary:
The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.

Condition or disease Intervention/treatment Phase
Melanoma Metastatic Kidney Cancer Drug: Interleukin-2 (IL-2) Phase 2

Detailed Description:
The current study will test single agent IL-2 given daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting in stage IV melanoma and kidney cancer to attempt to determine the response rate, how long the responses last, and median survival of this regimen in these two diseases. Responding patients and those with absence of disease progression may receive additional cycles of therapy every 3 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer
Study Start Date : March 2011
Primary Completion Date : February 2012
Study Completion Date : February 2012



Intervention Details:
    Drug: Interleukin-2 (IL-2)
    Daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting


Primary Outcome Measures :
  1. Response rate [ Time Frame: 9 weeks ]

Secondary Outcome Measures :
  1. how long the tumor shrinkage lasts [ Time Frame: 9 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have a histologic diagnosis of metastatic kidney cancer or malignant melanoma Patients may be either newly diagnosed with metastatic disease or may have received prior treatment for metastatic kidney cancer.
  2. Patients must have measurable disease on physical exam or radiologic studies.
  3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
  4. White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl; bilirubin, ALT, AST < 2 x upper limit of normal; serum creatinine < 2.0 mg/dl.
  5. Patients must undergo a low-level cardiac stress test (or similar cardiac evaluation such as dobutamine stress echocardiogram or radionuclide-based stress test) for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
  6. Patients with elevated temperatures > 100.5 F must have sources of occult infection excluded.
  7. Patients must be felt to have recovered from effects of prior therapy, such as > 2 weeks after prior chemotherapy.

Exclusion Criteria:

  1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate).
  2. Autoimmune disease such as inflammatory arthritis, which could be exacerbated by immune-based therapy.
  3. Prior history of psychiatric disorder, which could be exacerbated by interleukin-2.
  4. Lactation or pregnancy.
  5. Evidence of significant cardiovascular disease including history of recent (< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
  6. Current brain metastasis.

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 ClinicalTrials.gov identifier (NCT number): NCT01355562


Locations
United States, California
Highland Springs Medical Plaza
Beaumont, California, United States, 92223
Loma Linda University Cancer Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Walter Quan, Jr., M.D. Loma Linda University Cancer Center

Additional Information:
Responsible Party: Chien-Shing Chen, M.D., Ph.D., Loma Linda University
ClinicalTrials.gov Identifier: NCT01355562     History of Changes
Other Study ID Numbers: LLU1101
First Posted: May 18, 2011    Key Record Dates
Last Update Posted: October 5, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Melanoma
Kidney Neoplasms
Carcinoma, Renal Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs