A Multi-Institutional Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Malignant Neuro-Epithelial and Other Solid Tumors

• Status: Terminated
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

There is currently no standard treatment for patients with neuro-epithelial (brain) or other solid tumors in another part of the body who do not have adequate suitable autologous hematopoietic progenitor cells available and/or whose disease has relapsed after standard treatment. Allogeneic Hematopoietic Progenitor Cell Transplant may be a consideration for treatment of patients with recurrent chemo-responsive malignant (high grade) neuro-epithelial and other solid tumors or those who do not have suitable autologous hematopoietic progenitor cell availability. The procedure in which your own blood stem cells are transplanted to you is called an autologous (from your own) progenitor cell transplant and when cells from a matched donor are transfused is called an allogeneic progenitor cell transplant. The study is being conducted to evaluate the safety and effectiveness of a combination of drugs followed by an allogeneic hematopoietic progenitor cell transplant (HPCT). This treatment regimen is experimental in that although the individual drugs are commonly used to treat your disease, the specific combination used in this protocol followed by the transplant is experimental.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Collaborators: Children's Hospital Los Angeles; Nationwide Children's Hospital
• Treatments: Alemtuzumab; Cyclosporine; Cyclosporins; Etoposide; Etoposide phosphate; Fludarabine; Fludarabine phosphate; Melphalan; Mitogens; Mycophenolate mofetil; Mycophenolic Acid; Polystyrene sulfonic acid; Tacrolimus; Thiotepa

Criteria

Inclusion Criteria:

• Malignant (high-grade) neuro-epithelial and other solid tumors

• Patients have to be in at least, a chemo-responsive disease status defined as; any disease regression to chemotherapy when compared to its pre-treatment evaluation

• Patients with recurrent (or refractory) chemo-responsive disease or without suitable autologous hematopoietic progenitor cell availability

• Creatinine clearance or glomerular filtration rate (GFR) ≥50 ml/min/1.73m2, and not requiring dialysis

• Diffusing capacity of lung for carbon monoxide, or DLCO, (corrected for hemoglobin) ≥ 50% predicted. If unable to perform pulmonary function tests, then oxygen (O2) saturation ≥ 92% in room air

• Bilirubin ≤3x upper limit of normal (ULN) and alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 5x for age (with the exception of isolated hyperbilirubinemia due to Gilbert's syndrome)

Exclusion Criteria:

• Lack of histocompatible suitable related or unrelated donor/ graft source

• End-organ failure that precludes the ability to tolerate the transplant procedure, including conditioning

• Renal failure requiring dialysis

• Congenital heart disease resulting in congestive heart failure

• Ventilatory failure

• HIV infection

• Uncontrolled bacterial, viral, or fungal infections (currently taking medication yet clinical symptoms progress); stable, controlled disease with treatment is not an exclusion criteria

• Female of reproductive potential who is pregnant, planning to become pregnant during the study, or is nursing a child