Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Fenretinide in Treating Patients Who Have Undergone Surgery for Bladder Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 and over	NCI	MDA-ID-95236 NCI-G99-1621, NCT00004154, T98-0051, NCI-T98-0051

Objectives

1. Determine the efficacy, mechanism of action, and toxicity of fenretinide in patients at risk of recurrent superficial bladder cancer after complete resection of initial tumor.
2. Determine the treatment effects in modulating the expression of retinoid receptors, chromosomal abnormalities (numerical chromosomal abnormalities and DNA ploidy), apoptosis, and autocrine motility factor receptor (intermediate endpoint markers of recurrent disease) in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven solitary or multifocal superficial (stage Ta, grades 1-2) transitional cell carcinoma (TCC) of the bladder meeting 1 of the following criteria:
  • Newly diagnosed and no more than 4 weeks since resection
  • Secondary after being tumor free (including carcinoma in situ) for more than 12 months with no intravesical therapy within that 12 months

  OR




• Histologically proven Ta, T1, or Tis TCC of the bladder previously treated with BCG
  • Must have received 6 weeks of induction BCG followed by no evidence of disease by cystoscopy and cytology and then further treatment with 3 weekly doses of BCG



• Visible tumor totally resected within 4 weeks prior to study entry and no further surgery, intravesical therapy, or systemic therapy planned



• No prostatic, prostatic urethral, or upper tract TCC involvement by the index tumor at resection



• No metastatic disease

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• No concurrent systemic biologic therapy

Chemotherapy:

• See Disease Characteristics
• No prior systemic cytotoxic chemotherapy for bladder cancer
• At least 1 year since prior cytotoxic chemotherapy for nonbladder cancer
• No concurrent systemic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to the bladder
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• At least 3 months since prior high-dose vitamin A (greater than 25,000 IU) or beta carotene (at least 30 mg/day)
• At least 3 months since prior retinoid therapy

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Zubrod (ECOG) 0-2

Life expectancy:

• At least 2 years

Hematopoietic:

• WBC greater than 3,000/mm³
• Platelet count greater than 100,000/mm³
• Hemoglobin greater than 11.0 g/dL

Hepatic:

• SGOT or SGPT less than 1.5 times upper limit of normal (ULN)

Renal:

• Creatinine less than 2.0 mg/dL

Other:

• Triglyceride level less than 2.5 times ULN
• No other concurrent malignancy except nonmelanomatous skin cancer
• No other malignancy within the past 5 years unless currently disease free, at least 6 months since prior therapy, no current or planned active therapy, and expected disease-free survival at least 2 years
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 1 year after the study participation

Expected Enrollment

A total of 178 patients (89 per arm) will be accrued for this study.

Outline

This is a randomized, multicenter study. Patients are stratified according to lesion type (multifocal vs solitary). Patients are randomized to one of two treatment arms.

Patients receive either oral fenretinide or placebo on days 1-25. Courses repeat every 28 days for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of a second primary cancer requiring therapy.

Patients are followed every 3 months for 15 months.

Sabichi AL, Lerner SP, Atkinson EN, et al.: Phase III prevention trial of fenretinide in patients with resected non-muscle-invasive bladder cancer. Clin Cancer Res 14 (1): 224-9, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Anita Sabichi, MD, Protocol chair		Ph: 713-792-6363; 800-392-1611

Registry Information
Official Title		Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer
Trial Start Date		2000-06-15
Registered in ClinicalTrials.gov		NCT00004154
Date Submitted to PDQ		1999-10-12
Information Last Verified		2004-01-09
NCI Grant/Contract Number		CA16672, CA77150

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