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

NCT01355562 | Withdrawn Phase 2

• 1 other identifier: 5110062
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Melanoma; Metastatic Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

  9 weeks

Secondary Outcomes (1)

• how long the tumor shrinkage lasts

  9 weeks

Interventions

Interleukin-2 (IL-2) DRUG

Daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must have measurable disease on physical exam or radiologic studies.
• ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
• 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.
• 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.
• Patients with elevated temperatures \> 100.5 F must have sources of occult infection excluded.
• Patients must be felt to have recovered from effects of prior therapy, such as \> 2 weeks after prior chemotherapy.

You may not qualify if:

• Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate).
• Autoimmune disease such as inflammatory arthritis, which could be exacerbated by immune-based therapy.
• Prior history of psychiatric disorder, which could be exacerbated by interleukin-2.
• Lactation or pregnancy.
• 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.
• Current brain metastasis.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (2)

Highland Springs Medical Plaza

Beaumont, California, 92223, United States

Location

Loma Linda University Cancer Center

Loma Linda, California, 92354, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Melanoma; Kidney Neoplasms

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Walter Quan, Jr., M.D.

  Loma Linda University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: May 18, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

US (2)