Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


OBJECTIVES:

- Determine the maximum tolerated dose of yttrium Y90 monoclonal antibody m170
administered with paclitaxel and cyclosporine followed by autologous peripheral blood
stem cell transplantation in patients with hormone-refractory metastatic prostate
cancer.

- Determine the preliminary efficacy of this regimen in these patients.

OUTLINE: This is an open-label, dose-escalation study of yttrium Y 90 monoclonal antibody
m170 (Y90 MOAB m170). Patients are assigned to one of four cohorts.

After the first occurrence of hematologic dose-limiting toxicity in a patient, all
subsequent patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 4 days prior to
undergoing apheresis and continuing until 6 million CD34+ cells/kg are collected. After 2
patients in a cohort group experience hematologic dose-limiting toxicity, subsequent
patients undergo autologous peripheral blood stem cell (PBSC) transplantation.

- Cohort I: Patients receive unlabeled monoclonal antibody (MOAB) m170 IV over 5 minutes
followed by a tracer dose of indium In 111 monoclonal antibody m170 (In111 MOAB m170)
IV over 5-10 minutes on day 0 and unlabeled MOAB m170 IV followed by Y90 MOAB m170 IV
on day 7. Patients also receive oral cyclosporine every 12 hours on days -3 to 25.
Patients may undergo autologous PBSC transplantation on day 21 and receive G-CSF SC
daily beginning on day 21 and continuing until blood counts recover.

- Cohort II: Patients receive treatment as in cohort I. Patients also receive paclitaxel
IV over 3 hours on day 9.

- Cohort III and IV: Patients receive treatment as in cohort I without In111 MOAB m170.
Patients also receive paclitaxel as in cohort II.

Cohorts of 3 to 6 patients receive escalating doses of Y90 MOAB m170 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.

Patients are followed monthly for 3 months, every 3 months for 1 year, and then every 6
months for 1 year.

PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study within 36
months.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Carol M. Richman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis

Authority:

United States: Federal Government

Study ID:

CDR0000068364

NCT ID:

NCT00009750

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

University of California Davis Cancer CenterSacramento, California  95817