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

This study has been withdrawn prior to enrollment.
(Primary Investigator is no longer employed at LLU as of 02/29/12.)
Sponsor:
Information provided by (Responsible Party):
Chien-Shing Chen, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01355562
First received: April 28, 2011
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Melanoma
Metastatic Kidney Cancer
Drug: Interleukin-2 (IL-2)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Response rate [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • how long the tumor shrinkage lasts [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Interleukin-2 (IL-2)
    Daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Chien-Shing Chen, M.D., Ph.D., Loma Linda University
ClinicalTrials.gov Identifier: NCT01355562     History of Changes
Other Study ID Numbers: LLU1101
Study First Received: April 28, 2011
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

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
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 August 20, 2014