PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer

NCT00090870 | Terminated Phase 2 Results DMC

• 4 other identifiers: CDR0000378049MUSC-100614CELGENE-MUSC-100614MUSC-HR-10423
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate

  To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide

  while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year

Secondary Outcomes (3)

• Duration of Response

  time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.

• Frequency of Adverse Events Assessed by NCI CTC Version 2

  From the first day of treatment until the end of treatment visit, an average of 6 months

• Progression-free Survival

  From registration until diease progression or death, whichever comes first.

Study Arms (1)

PEG-Intron, BM-CSF and thalidomide

EXPERIMENTAL

Biological: PEG-interferon alfa-2b; Biological: GM-CSF; Drug: thalidomide

Interventions

PEG-interferon alfa-2b BIOLOGICAL

Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.

PEG-Intron, BM-CSF and thalidomide

GM-CSF BIOLOGICAL

GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle

PEG-Intron, BM-CSF and thalidomide

thalidomide DRUG

200mg daily by mouth

PEG-Intron, BM-CSF and thalidomide

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Metastatic disease * Measurable disease * Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI * Histologic confirmation required if measurable disease is confined to a solitary lesion * The following are not considered measurable disease: * Bone disease only * Pleural or peritoneal metastases * CNS lesions * Irradiated lesions unless disease progression was documented after prior radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * No decompensated liver disease Renal * Creatinine ≤ 2.0 mg/dL Immunologic * No known or suspected hypersensitivity to interferon alfa or to any excipient or vehicle included in the formulation or delivery system * No history of autoimmune disease * No autoimmune hepatitis * No immunosuppressed transplantation recipients Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after study participation * No pre-existing thyroid abnormalities for which thyroid function cannot be maintained in the normal range * No severe psychiatric condition or disorder, including suicidal ideation or attempt * No other active malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy Surgery * Not specified

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

peginterferon alfa-2b; Granulocyte-Macrophage Colony-Stimulating Factor; Thalidomide

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; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Kate Anderton
• Organization: Medical University of South Carolina

anderton@musc.edu

843-792-2708

Study Officials

• Uzair B. Chaudhary, MD

  Medical University of South Carolina

  STUDY CHAIR

• Gustavo Leone

  Medical University of South Carolina, Hollings Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 8, 2004
• Study Start: April 1, 2002
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 12, 2018
• Results First Posted: July 12, 2018

Record last verified: 2018-06

Locations

US (1)