Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed over 21 MSKCC-90087 NCI-V90-0149

Objectives

I.  Evaluate the safety and toxicity of repeated administrations of 
rhenium-186 hydroxyethylidene diphosphonate in patients with skeletal 
metastases from prostate cancer.

II.  Evaluate the extent and duration of the palliative response produced by 
this radiopharmaceutical in this patient population.

Entry Criteria

Disease Characteristics:

Prostate cancer with painful bony metastases

Previously treated on Study 326 and completed 8 weeks of
follow-up, as follows:

  Had 2 successive weeks with either 50% decrease in pain
  (VASPI or VASPR scales of the Memorial Pain Assessment
  Card) or 50% decrease in analgesic use

  No grade 3/4 toxicity (WBC, granulocytes, platelets, or
  creatinine)

No CNS metastases or cord compression (absence of cord
compression documented by myelography or MRI, when clinically
indicated)

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No chemotherapy since completion of Study 326

Endocrine therapy:
  Failed or not candidates for hormonal therapy
  At least 2 weeks since termination of or change in therapy

Radiotherapy:
  No external radiotherapy since completion of Study 326

Surgery:
  Not specified

Other:
  No other investigational agent within 30 days
  No concurrent anticancer therapy during this trial

Patient Characteristics:

Age:
  Over 21

Performance status:
  Karnofsky greater than 60%

Life expectancy:
  At least 12 weeks

Hematopoietic:
  WBC at least 4,000
  AGC greater than 2,000
  Platelets greater than 150,000

Hepatic:
  Not specified

Renal:
  Creatinine no greater than 1.5 mg/dl

Cardiovascular:
  No AHA class III heart failure

Other:
  No pregnant or lactating women
  Geographic proximity for follow-up

Expected Enrollment

The number of patients accrued will depend on the number of patients who 
complete Study 326.

Outline

Nonrandomized study.

Radioisotopic Therapy.  Rhenium-186 Hydroxyethylidene Diphosphonate, 186-Re 
HEDP.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Howard Scher, MD, Protocol chair		Ph: 646-422-4330; 800-525-2225 Email: scherh@mskcc.org