Clinical trial · Interventional
Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer
A PHASE III STUDY OF THREE DIFFERENT DOSES OF SURAMIN (NSC #34936) ADMINISTERED WITH A FIXED DOSING SCHEDULE IN PATIENTS WITH ADVANCED PROSTATE CANCER
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomized phase III trial to compare the effectiveness of low, intermediate, and high dose suramin in treating men with stage IV prostate cancer that is refractory to hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of suramin is more effective for prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| suramin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Low dose suramin
- description
- Low dose suramin
- interventionNames
- Drug: suramin
- type
- EXPERIMENTAL
- label
- Intermediate dose suramin
- description
- Intermediate dose suramin
- interventionNames
- Drug: suramin
- type
- EXPERIMENTAL
- label
- High dose suramin
- description
- High dose suramin
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven adenocarcinoma of the prostate with progressive metastatic or progressive regional nodal disease
* PSA evidence of progression defined as at least 50% increase over baseline on at least 2 measurements at least 2 weeks apart
* Measurable disease preferred but not required
* Bone scan abnormalities acceptable provided PSA at least 10 ng/mL
* No minimum PSA value required if measurable disease present
* Progression after or during an adequate trial of hormonal therapy
* No more than 3 prior hormonal interventions for progressive disease
* One prior hormonal intervention is defined by any of the following:
* Concurrent testicular and adrenal androgen ablation (e.g., leuprolide, goserelin, orchiectomy, or diethylstilbestrol (DES) plus flutamide, bicalutamide, nilutamide, megestrol, or other antiandrogen)
* Initial LHRH agonist followed by orchiectomy provided no progression prior to orchiectomy
* Prior intermittent androgen deprivation on protocol SWOG-9346
* Corticosteroids for metastatic disease or in conjunction with aminoglutethimide or ketoconazole
* Two prior hormonal interventions are defined by the following:
* Antiandrogen given for disease progression more than 3 months after initial hormonal therapy
* Prior neoadjuvant or adjuvant deprivation for treatment of nonmetastatic disease not considered a prior hormonal intervention
* Antiandrogen withdrawal not considered a separate hormonal intervention
* At least 4 weeks since antiandrogen withdrawal or megestrol withdrawal
* Failure to respond to (i.e., no decrease in PSA at 2 and 4 weeks) or progression after a transient response to antiandrogen withdrawal or megestrol withdrawal required
* Primary testicular androgen suppression (e.g., LHRH agonist or DES) continues during study
* No brain metastases or other CNS disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* CALGB 0-2 OR
* Zubrod 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* WBC at least 3,000/mm3
* Absolute neutrophil count at least 1,200/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 9 g/dL
* Fibrinogen at least 200 mg/dL
* No prior hemorrhagic or thrombotic disorders
Hepatic:
* Bilirubin normal
* AST/ALT no greater than 2.5 times normal
* Prothrombin time, partial thromboplastin time, and thrombin time normal
Renal:
* Creatinine clearance at least 70 mL/min
Other:
* No primary muscle disease
* No active, uncontrolled bacterial, viral, or fungal infection
* No grade 1 or worse peripheral neuropathy
* No underlying medical condition that would preclude study
* No other serious medical illness that limits survival to less than 3 months
* No psychiatric condition that would preclude informed consent
* No other malignancy within the past 5 years except inactive nonmelanomatous skin cancer or adequately treated stage I or II cancer in remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy for metastatic disease
Chemotherapy:
* No prior chemotherapy (including estramustine) for metastatic disease
Endocrine therapy:
* No concurrent megestrol or other hormonal agents
* No concurrent systemic or inhaled corticosteroids (intranasal and topical steroids allowed)
Radiotherapy:
* At least 4 weeks since prior radiotherapy (8 weeks for strontium therapy)
Other:
* No prior experimental therapy for metastatic disease
* No concurrent heparin, warfarin, or aspirinReferences
Publications (15)
- BACKGROUNDHalabi S, Vogelzang NJ, Kornblith AB, Ou SS, Kantoff PW, Dawson NA, Small EJ. Pain predicts overall survival in men with metastatic castration-refractory prostate cancer. J Clin Oncol. 2008 May 20;26(15):2544-9. doi: 10.1200/JCO.2007.15.0367. PMID 18487572
- BACKGROUNDD'Amico AV, Halabi S, Vogelzang NJ, et al.: A reduction in the rate of PSA rise following chemotherapy in patients with metastatic hormone refractory prostate cancer (HRPC) predicts survival: results of a pooled analysis of CALGB HRPC trials. [Abstract] J Clin Oncol 22 (Suppl 14): A-4506, 383s, 2004.
- BACKGROUNDHalabi S, Small EJ, Kantoff PW, Kattan MW, Kaplan EB, Dawson NA, Levine EG, Blumenstein BA, Vogelzang NJ. Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer. J Clin Oncol. 2003 Apr 1;21(7):1232-7. doi: 10.1200/JCO.2003.06.100. PMID 12663709
- BACKGROUNDGilligan TD, Halabi S, Kantoff PW, et al.: African-American race is associated with longer survival in patients with metastatic hormone-refractory prostate cancer (HRCaP) in four randomized phase III Cancer and Leukemia Group B (CALGB) trials. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-725, 2002.
- RESULTGeorge DJ, Halabi S, Shepard TF, Sanford B, Vogelzang NJ, Small EJ, Kantoff PW. The prognostic significance of plasma interleukin-6 levels in patients with metastatic hormone-refractory prostate cancer: results from cancer and leukemia group B 9480. Clin Cancer Res. 2005 Mar 1;11(5):1815-20. doi: 10.1158/1078-0432.CCR-04-1560. PMID 15756004
- RESULTTaplin ME, George DJ, Halabi S, Sanford B, Febbo PG, Hennessy KT, Mihos CG, Vogelzang NJ, Small EJ, Kantoff PW. Prognostic significance of plasma chromogranin a levels in patients with hormone-refractory prostate cancer treated in Cancer and Leukemia Group B 9480 study. Urology. 2005 Aug;66(2):386-91. doi: 10.1016/j.urology.2005.03.040. PMID 16098367
- RESULTAhles TA, Herndon JE 2nd, Small EJ, Vogelzang NJ, Kornblith AB, Ratain MJ, Stadler W, Palchak D, Marshall ME, Wilding G, Petrylak D, Holland JC; Cancer and Leukemia Group B. Quality of life impact of three different doses of suramin in patients with metastatic hormone-refractory prostate carcinoma: results of Intergroup O159/Cancer and Leukemia Group B 9480. Cancer. 2004 Nov 15;101(10):2202-8. doi: 10.1002/cncr.20655.