Clinical trial · Interventional
Biological Therapy in Treating Patients With Prostate Cancer
A Phase I Safety Study Of Xcellerate In Patients With Hormone Refractory Prostate Cancer
NCT00039299CI-TRIAL-00009895completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's T cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of T-cell therapy in treating patients who have 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Evidence of androgen-independent disease
* Patient must have received prior primary hormonal therapy (e.g., orchiectomy or gonadotropin-releasing hormone analog with or without antiandrogen)
* Demonstrated disease progression by any 1 of the following:
* Elevated PSA level (at least 5 ng/mL) that has serially risen from baseline on 2 occasions at least 1 week apart
* At least 1 new osseous lesion on bone scan
* More than 25% increase in the sum of the products of the perpendicular diameters of all bidimensionally measurable sites of disease
* No CNS metastases
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* ECOG 0-1
Life expectancy:
* At least 3 months
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGPT no greater than 1.5 times ULN
* Hepatitis B surface antigen negative
* No active or chronic hepatitis B or C
* No other hepatic dysfunction that would preclude study
Renal:
* Creatinine less than 2.0 mg/dL
* Calcium less than 11 mg/dL
* No renal dysfunction that would preclude study
* No symptomatic hypercalcemia
Cardiovascular:
* No New York Heart Association class III or IV heart disease
Pulmonary:
* No pulmonary disease requiring inhaled steroids or bronchodilators
Other:
* No history of HIV 1 or 2 or human T-cell lymphotrophic virus (HTLV) 1 or 2
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
* No history of autoimmune disease (e.g., rheumatoid arthritis or multiple sclerosis)
* No other major organ system dysfunction
* No gastrointestinal, neurologic, or psychiatric dysfunction that would preclude study
* Human anti-mouse antibody negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent growth factors, interleukin, interferons, or cytokines
Chemotherapy:
* No prior chemotherapy or other systemic chemotherapy agent for prostate or any other cancer
Endocrine therapy:
* Prior aminoglutethimide allowed
* At least 4 weeks since prior flutamide
* At least 6 weeks since prior bicalutamide or nilutamide
* Concurrent luteinizing hormone-releasing hormone agonists should be continued
* No concurrent corticosteroids or dexamethasone
* No concurrent anti-androgens (e.g., flutamide, bicalutamide, or nilutamide)
Radiotherapy:
* At least 4 weeks since prior local radiotherapy
* No prior radiopharmaceutical therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* Prior ketoconazole or PC-SPES allowed
* At least 1 week since prior antibiotic, antifungal, or antiviral agents
* At least 4 weeks since other prior systemic therapy for prostate cancer (except bisphosphonates or hormonal therapy)
* At least 6 weeks since prior investigational drugs or devices
* No other concurrent therapy for this disease
* No concurrent participation in another clinical trial
* No concurrent bisphosphonates unless initiated prior to study
* No concurrent immunosuppressive drugs
* No other concurrent experimental therapiesReferences
Publications (0)
Data not yet available
No reference posted for this study.