Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer

NCT00003656 | Completed Phase 2 Results

• 3 other identifiers: 9804003327NYWCCC-0498-209NCI-V98-1490
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa may interfere with the growth of cancer cells. PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have metastatic kidney cancer.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer; recurrent renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Best Response as Measured by CT, Bone Scans, and Clinical Progression

  After 8 weeks

• Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose

  In 30 days after the last dose, an average of 1 year.

Secondary Outcomes (2)

• Change in Retinoic Acid Receptor Expression on Tissue as Measured by Number of Subjects With the Presence of Peripheral Blood Lymphocytes During the First and Fifth Dose

  At baseline and 5th week

• Duration of Response (Progression-free Survival) as Measured by CT, Bone Scans, and Clinical Progression From Initiation of Therapy Until an Increase of ≥ 25% From the Smallest Sum of All Tumor Measurements Obtained During the Best Response

  At 6 months and 12 months

Study Arms (1)

All subjects

EXPERIMENTAL

Weekly ATRA-IV with recombinant interferon alfa

Biological: recombinant interferon alfa; Drug: tretinoin liposome

Interventions

recombinant interferon alfa BIOLOGICAL

All subjects

tretinoin liposome DRUG

All subjects

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell carcinoma * Bidimensionally measurable disease * No active brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * No coagulation disorders Hepatic: * Bilirubin less than 1.5 mg/dL * SGOT and SGPT less than 112.5 IU/L each or less than 2.5 times upper limit of normal * No clinically significant hepatic disease, including autoimmune hepatitis Renal: * Creatinine less than 2 mg/dL OR * Creatinine clearance greater than 50 mL/min * No clinically significant renal disease Cardiovascular: * No clinically significant cardiac disease * No thrombophlebitis Pulmonary: * No severe debilitating pulmonary disease * No pulmonary embolism Other: * No history of diabetes mellitus prone to ketoacidosis * No known hypersensitivity to retinoids or retinoic acid derivatives or to interferon or any component of the injection for this study * No thyroid abnormalities that hinder maintaining thyroid function at the normal range * No severe infection * No severe malnutrition * No clinically significant retinal abnormalities * No pre-existing psychiatric condition, especially depression or a history of severe psychiatric disorder * No other concurrent malignancy except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 effective methods of contraception during and for 1 month after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than 1 prior biological response modifier therapy or immunotherapy Chemotherapy: * No more than 1 prior chemotherapy regimen Endocrine therapy: * No concurrent steroids Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * At least 4 weeks since prior major surgery Other: * No prior retinoid therapy

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (2)

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

• Goldberg JS, Vargas M, Rosmarin AS, Milowsky MI, Papanicoloau N, Gudas LJ, Shelton G, Feit K, Petrylak D, Nanus DM. Phase I trial of interferon alpha2b and liposome-encapsulated all-trans retinoic acid in the treatment of patients with advanced renal cell carcinoma. Cancer. 2002 Sep 15;95(6):1220-7. doi: 10.1002/cncr.10809.

  PMID: 12216088 BACKGROUND

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Interferon-alpha

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)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Sharon Singh
• Organization: Weill Cornell Medical College

shs4011@med.cornell.edu

(646) 962-9340

Study Officials

• David M. Nanus, MD

  Weill Medical College of Cornell University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: November 1, 1999
• First Posted: January 27, 2003
• Study Start: January 1, 1999
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: March 18, 2022
• Results First Posted: March 18, 2022

Record last verified: 2022-03

Locations

US (2)