Clinical trial · Interventional
Monoclonal Antibody Therapy Plus Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Combined Modality Radioimmunotherapy For Hormone Refractory Metastatic Prostate Cancer With Two Cycles Of Escalating Dose 90Y-DOTA-Peptide-m170 And Fixed, Low Dose Paclitaxel With Blood Stem Cell Support And Cyclosporin For HAMA Suppression
- 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)
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy and chemotherapy with peripheral stem cell transplantation may be an effective treatment for metastatic prostate cancer. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy plus chemotherapy followed by peripheral stem cell transplantation in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclosporine | Drug | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| indium In 111 monoclonal antibody m170 | Radiation | — | UNRESOLVED |
| monoclonal antibody m170 | Biological | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| yttrium Y 90 monoclonal antibody m170 | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed hormone-refractory metastatic prostate cancer * Hormonal ablation (surgical or chemical) at least 3 months prior to study * HAMA titer negative * Less than 25% bone marrow involvement by metastatic prostate cancer PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,00/mm\^3 * Hemoglobin at least 10.0 g/dL (without transfusion) * No chronic transfusion requirement Hepatic: * Bilirubin no greater than 1.3 mg/dL * AST no greater than 1.5 times normal Renal: * Creatinine less than 1.5 mg/dL Cardiovascular: * LVEF at least 50% by MUGA * No disseminated intravascular coagulation Pulmonary: * FEV1 at least 65% of predicted * FVC at least 65% of predicted * Corrected DLCO at least 60% Other: * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior murine protein (e.g., ProstaScint) Chemotherapy: * At least 4 weeks since prior standard dose chemotherapy Endocrine therapy: * See Disease Characteristics Radiotherapy: * At least 4 weeks since prior external beam radiotherapy * No prior radiotherapy to no more than 25% of total skeleton Surgery: * See Disease Characteristics Other: * No concurrent oral anticoagulants (low dose coumadin for central line thrombosis prophylaxis allowed) * No concurrent chronic transfusions
References
Publications (0)
Data not yet available