Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:5/18/2018
Start Date:January 2017
End Date:January 2022
Contact:Connie Collins, RN
Email:ccolli23@jhmi.edu
Phone:410-955-1017

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A Pilot Study of Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer

Men with progressive metastatic Castration-Resistant Prostate Cancer post first-line
treatment with either androgen deprivation therapy alone or androgen deprivation therapy plus
docetaxel who have an identified related female donor (mother sister, daughter, second degree
relative such as granddaughter or niece) will undergo bone marrow transplantation followed by
post-transplant Cytoxan (PT/Cy) and testosterone.

Men will undergo pre-transplant screening evaluation and be enrolled in the study. Subjects
will be treated with a standard non-myeloablative conditioning regimen consisting of
Fludarabine 30 mg/m2 IV Days -6 to -2; Cy 14.5 mg/kg IV Days -6 and -5; Total body
irradiation (TBI) 200 cGy Day -1. On Day 0, patients will be infused with non-T-cell depleted
bone marrow from a related female donor. Patients will receive GVHD prophylaxis consisting
of: Cy 50mg/kg IV on Days +3 and +4; tacrolimus (IV or PO) beginning on Day +5 [dose adjusted
to maintain trough level of 5-15 ng/mL] through day+180; Mycophenolate mofetil (MMF) 15 mg/kg
PO TID, with a maximum dose of 1g TID beginning on Day +5 through Day +35. Patients will
receive filgrastim (G-CSF) 5 mcg/kg/day beginning on Day +5 and continued until ANC ≥
1500/mm3. Lastly, to produce maintenance tumor antigen stimulation, patients will be
maintained on continuous LHRH agonist/antagonist therapy (if not previously surgically
castrated) to suppress endogenous testosterone production throughout the treatment period;
testosterone cypionate 400 mg IM will be administered on Day +60, +90, and +120 (every 30
days x 3 doses). Patients who achieve biochemical CR will stop LHRH agonist/antagonist
treatment at day 180. Patients will be followed for 3 years post-BMT.

Inclusion Criteria:

- Performance status ≤1

- Age ≥18 years and ≤ 75 years old

- Histologically-confirmed adenocarcinoma of the prostate

- Treated with continuous androgen ablative therapy (either surgical castration or LHRH
agonist/antagonist) with documented castrate level of serum testosterone (<50 ng/dl)

- Metastatic disease radiographically documented by CT or bone scan

- Patient must be HLA typed at high resolution using DNA based typing at the following
loci: HLA-A, -B, -C, and DRB1

- Patient must have available one or more potential first (biologic mother, sister,
half-sister, or daughter) or second-degree related female donor. Mothers and daughters
have a 100% chance of being haploidentical matches, sisters a 75% chance of being
matched or haploidentical, and second degree relatives have a 50% chance of being
haploidentical matches. The donor and recipient must be HLA identical for at least one
antigen at HLA-A, -B, -C and HLA-DRB1.

- Screening PSA must be ≥ 1.0 ng/mL.

- Prior therapy with one second line hormonal therapy is allowed (i.e. bicalutamide,
nilutamide, flutamide, ketoconazole, abiraterone, enzalutamide, ARN-509).

- Prior docetaxel (≤ 6 cycles) as first line therapy

- Cardiac ejection fraction at rest must be ≥ 40%

- Acceptable liver function: Bilirubin < 2.5 mg/dL (unless due to Gilbert's disease, AST
(SGOT) and ALT (SGPT) < 5 times upper limit of normal.

- Acceptable renal function: Serum creatinine within normal range.

- Pulmonary function: DLCO (corrected for hemoglobin), FEV1 and FVC >50% predicted.

- At least 4 wks since prior radiation or surgery with full recovery (no persistent
toxicity ≥ Grade 1)

- Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

- Prior treatment with Sipuleucel-T, radium-223, strontium-89, or samarium-153

- Prior chemotherapy (docetaxel, cabazitaxel) for castrate resistant prostate cancer

- Evidence of serious and/or unstable pre-existing medical, psychiatric or other
condition (including laboratory abnormalities) that could interfere with patient
safety or provision of informed consent to participate in this study

- Active uncontrolled infection, including known history of HIV/AIDS or hepatitis B or
C.

- Any psychological, familial, sociological, or geographical condition that could
potentially interfere with compliance with the study protocol and follow-up schedule.
We found this trial at
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Phone: 410-955-1017
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