Oblimersen and Interferon Alfa in Treating Patients With Metastatic Renal Cell Cancer

NCT00059813 | Completed Phase 2

• 4 other identifiers: NCI-2012-02828PHII-425828N01CM17101
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of combining oblimersen with interferon alfa in treating patients who have metastatic renal cell (kidney) cancer. Interferon alfa may interfere with the growth of tumor cells. Oblimersen may increase the effectiveness of interferon alfa by making tumor cells more sensitive to the drug.

Conditions

Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate based on the Response Evaluation Criteria In Solid Tumors (RECIST)

  Confidence intervals for the response rate will be established by calculating exact 95% confidence limits for a binomial parameter.

  Start of the treatment until disease progression/recurrence, assessed up to 5 years

Secondary Outcomes (3)

• Overall survival

  Time from first day of treatment to time of death due to any cause, assessed up to 5 years

• Progression free survival

  Time from first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 5 years

• Time to progression

  Time from first day of treatment to the first observation of disease progression or death due to disease, assessed up to 5 years

Study Arms (1)

Treatment (recombinant interferon alfa, oblimersen sodium)

EXPERIMENTAL

Patients receive oblimersen IV continuously on days 1-7 and interferon alfa subcutaneously on days 4, 6, 8, 10, and 12 of course 1 and on days 1, 3, 5, 8, 10, and 12 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive an additional 2 courses past CR.

Biological: recombinant interferon alfa; Biological: oblimersen sodium; Other: pharmacological study

Interventions

recombinant interferon alfa BIOLOGICAL

Given SC

Also known as: Alferon N, alpha interferon, IFN-A, Intron A, Roferon-A

Treatment (recombinant interferon alfa, oblimersen sodium)

oblimersen sodium BIOLOGICAL

Given IV

Also known as: augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense

Treatment (recombinant interferon alfa, oblimersen sodium)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (recombinant interferon alfa, oblimersen sodium)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed, measurable metastatic renal cell cancer; if a nephrectomy was performed in the setting of metastatic disease, post-nephrectomy progression of metastases must be documented
• Performance status 0-2 (SWOG), life expectancy \> 3 months
• Prior radiation must have been completed \> 4 weeks before enrollment, with measurable disease outside of the radiation port
• WBC \> 3500/μl
• Absolute neutrophil count \> 1500/μl
• Platelets \> 100,000/μl
• Transaminases \< 2 x institutional upper limit of normal
• Serum bilirubin \< 1.5 x institutional upper limit of normal (if Gilbert's, up to 2 x upper limit)
• Serum alkaline phosphatase \< 2.5 x institutional upper limit of normal
• Patients with hepatic metastases may have 50% higher levels of all the above-listed parameters
• Serum creatinine \< 1.5 x institutional upper limit of normal
• Patients with active or recently-treated autoimmune disease are excluded, as are patients currently receiving or expected to require corticosteroid therapy
• Prior malignancy is limited to adequately treated non-melanoma skin cancer, cervical carcinoma-in-situ, or any other malignancy for which the patient has been disease-free for at least 5 years
• Because the effects of G3139 on the unborn fetus or newborn infant are unknown, pregnant or lactating women are excluded, and patients with reproductive potential must agree to use a medically-acceptable form of birth control
• Patients must have fully recovered from the effects of any prior surgery or medical illness such as infection; those with psychosocial problems that might compromise safety or protocol compliance are excluded

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Interferon-alpha; Interferon Alfa-n3; Introns; Interferon alpha-2; oblimersen

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Kim Margolin

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: August 1, 2003
• Primary Completion: June 1, 2005
• Last Updated: August 26, 2013

Record last verified: 2013-08

Locations

US (1)