Interleukin-7 in Treating Patients With Metastatic Melanoma or Locally Advanced or Metastatic Kidney Cancer

NCT00492440 | Terminated Phase 1

• 2 other identifiers: CLI-107-0407-C-0114
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Interleukin-7 may stimulate the white blood cells to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with metastatic melanoma or locally advanced or metastatic kidney cancer.

Conditions

Kidney Cancer; Melanoma (Skin)

Keywords

recurrent renal cell cancer; stage IV renal cell cancer; stage III renal cell cancer; recurrent melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• Safety of recombinant interleukin-7 (IL-7)

Secondary Outcomes (4)

• Pharmacokinetics and pharmacodynamics of IL-7

• Comparison of the biological and clinical effects of recombinant IL-7 with non glycosylated IL-7

• Potential antitumor effect of recombinant IL-7

• Dose and administration schedule of recombinant IL-7

Study Arms (1)

CYT107 (r-hIL-7)

EXPERIMENTAL

Biological: recombinant interleukin-7; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Genetic: protein expression analysis; Other: flow cytometry; Other: immunoenzyme technique; Other: immunologic technique; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

recombinant interleukin-7 BIOLOGICAL

CYT107 (r-hIL-7)

gene expression analysis GENETIC

CYT107 (r-hIL-7)

polymerase chain reaction GENETIC

CYT107 (r-hIL-7)

protein expression analysis GENETIC

CYT107 (r-hIL-7)

flow cytometry OTHER

CYT107 (r-hIL-7)

immunoenzyme technique OTHER

CYT107 (r-hIL-7)

immunologic technique OTHER

CYT107 (r-hIL-7)

laboratory biomarker analysis OTHER

CYT107 (r-hIL-7)

pharmacological study OTHER

CYT107 (r-hIL-7)

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Melanoma * Metastatic disease * Renal cell carcinoma * Locally advanced and unresectable disease OR metastatic disease * Refractory to standard therapy OR ineligible to receive standard therapy * Measurable or evaluable disease * Previously received high-dose interleukin-2 OR have a contraindication for this treatment * No previously untreated or unstable brain metastases * No splenic metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * PT/PTT ≤ 1.5 times upper limit of normal (ULN) * Creatinine \< 1.5 times ULN * AST and ALT \< 2.5 times ULN * Conjugated (Direct) bilirubin ≤ 1.25 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * LVEF ≥ 45% by cardiac stress test (e.g., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) for patients meeting any of the following criteria: * History of ECG abnormalities * Symptoms of cardiac ischemia * At least 50 years of age and over * Familial or personal history of heart failure * Previously treated with antimitotic agents susceptible to trigger heart failure * FEV\_1 \> 60% of predicted (for patients with a prolonged smoking history or symptoms of respiratory dysfunction) * No concurrent cognitive impairment or likelihood of developing cognitive impairment on study therapy * No concurrent splenomegaly or proliferative hematologic disease * No documented HIV positivity * No acute hepatitis A or hepatitis B or C * Positive hepatitis B serology indicative of previous immunization (i.e., HBs Ab positive and HBc Ab negative) allowed * Positive hepatitis C serology allowed provided HCV RNA load by PCR is negative * Resting blood pressure ≤ 140/90 mm Hg on standard antihypertensive therapy * Untreated hypertensive patients who received standard antihypertensive therapy allowed provided hypertension is well controlled * No QTc prolongation ≥ 470 msec * No prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities * No active infection requiring systemic treatment and/or hospitalization within the past 28 days * Patients who have completed therapy or are clinically stable on therapy, in the opinion of the investigator, are eligible * No history of autoimmune disease * No history of severe asthma * No history of medical or psychiatric disease that would preclude study treatment * No documented cirrhosis or documented acute hepatitis PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 2 weeks since prior systemic corticosteroid therapy * More than 4 weeks since prior and no other concurrent cytotoxic therapy, immunotherapy, biological agents (i.e., cytokines, growth factors, or monoclonal antibodies), or antitumor vaccines * More than 7 days since prior hepatotoxic drugs unless medically necessary * More than 2 days since prior alcohol consumption * More than 1 day since prior acetaminophen use * No prior splenectomy * No prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation * No concurrent palliative therapy * No concurrent chemotherapy * No concurrent chronic anticoagulation (i.e., high-dose warfarin or heparin) * Warfarin dose 1 to 2 mg/day allowed * No concurrent chronic medications for asthma * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cytheris SA: lead
• Cytheris, Inc.: collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Melanoma; Carcinoma, Renal Cell

Interventions

Interleukin-7; Gene Expression Profiling; Polymerase Chain Reaction; Flow Cytometry; Immunoenzyme Techniques; Immunologic Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Genetic Techniques; Investigative Techniques; Nucleic Acid Amplification Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Immunoassay; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Steven A. Rosenberg, MD, PhD

  NCI - Surgery Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: May 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 18, 2012

Record last verified: 2012-10

Locations

US (1)