Low-dose Cyclophosphamide and Outpatient IV Interleukin-2 in Metastatic Melanoma

NCT01833767 | Withdrawn Phase 2

• 1 other identifier: 12-12
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine response rates by administering low dose cyclophosphamide on day 1, followed by 5 days of outpatient IL2.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• Response Rate

  One year

Secondary Outcomes (1)

• Median Survival

  One year

Study Arms (1)

Cyclophosphamide and Interleukin-2

EXPERIMENTAL

Cytoxan IV on day 1, IL2 IV on days 1-5

Drug: Cyclophosphamide and Interleukin 2

Interventions

Cyclophosphamide and Interleukin 2 DRUG

Cytoxan IV day 1, IL2 IV days 1-5

Also known as: Cytoxan, IL2

Cyclophosphamide and Interleukin-2

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 melanoma. Patients may have received prior systemic therapy or may be previously untreated.
• 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 \< 3 x upper limit of normal; serum creatinine \< 2.0 mg/dl.
• Patients must undergo a low-level cardiac stress test as a screen 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.
• Women of childbearing potential must have a negative pregnancy test and adequate precautions to prevent pregnancy during treatment must be taken.
• Patient consent must be obtained prior to entrance onto study.

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 untreated brain metastasis.

Sponsors & Collaborators

• Western Regional Medical Center: lead

Study Sites (1)

Western Regional Medical Center Inc

Goodyear, Arizona, 85338, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Cyclophosphamide; 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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Walter Quan, MD

  Western Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: April 14, 2013
• First Posted: April 17, 2013
• Study Start: October 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

US (1)