Stem Cell Transplantation for Metastatic Solid Tumors

NCT00001880 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 99006499-H-0064
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research study is to identify other types of cancer (malignant neoplasms) that may be treatable with stem cell transplantation (allogenic peripheral blood stem cell transplantation. Patients with a variety of different types of cancerous tumors that have spread (metastasized) and whose conditions have not improved with stand therapy, will be eligible to participate. Those patients selected to participate in the study will undergo a procedure known as a "mini-transplant". The mini-transplant is a transplantation of stem-cells collected from a sibling (brother or sister) of the patient. Unlike traditional bone marrow transplants, the mini-transplant does not require intense chemotherapy or radiation therapy. Because of this, patients experience fewer and less severe side effects. This study is open to patients diagnosed with a variety of metastatic solid tumors including esophageal, gastric (stomach), colon, rectal, liver tumors (hepatoma), cancer of the biliary system (cholangiocarcinoma), cancer of the pancreas, lung, breast, prostate, bone (sarcoma), adrenal basal cell, bladder, and adenocarcinomas of unk primary origin.

Conditions

Neoplasm Metastasis

Keywords

Engraftment; Peripheral Blood Stem Cells; Non-Myeloablative Bone Marrow Transplantation; Metastatic Solid Tumors; Graft-Versus-Host Disease; Cancer; Tumor

Outcome Measures

Primary Outcomes (1)

• Number of Participants Based on Tumor Response Criteria With Anti-tumor Effect Induce by Graft-versus-tumor Effect.

  To identify an anti-tumor effect of allogenic PNSC transplantation by induction of a graft-versus-tumor (GVT) effect in patients with a diversity of metastatic solid tumors, which are refractory to standard therapy. Tumor response assessed as follows: Complete response (CR): disappearance of all signs and symptoms of metastatic disease for a period of at least one month. Partial response (PR): a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month. No new metastatic lesions may appear. Stable disease (SD): tumor measurements not meeting the criteria of CR, PR, or PD. Progressive disease (PD): increase of 25% or greater in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the development of any new metastatic disease.

  one year

Secondary Outcomes (4)

• Number of Participants That Achieved Engraftment

  Day 100

• Number of Participants Who Received Donor Lymphocyte Infusion to Achieve Tumor Regression or Prevent Graft Failure

  2 years

• Number of Participants Who Developed Acute GVHD Grade 2 and Higher

  Day 100

• Number of Participants Who Developed Chronic GVHD

  Day 100 to year 2

Study Arms (1)

Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors

EXPERIMENTAL

Cyclosporin beginning day -4 then stem cells given on Day 0 followed by intravenous Methotrexate on days +1, +3, and +6.

Drug: methotrexate; Drug: Cyclosporin

Interventions

methotrexate DRUG

Cyclosporin beginning day -4 and intravenous Methotrexate on days +1, +3, and +6 will be given

Also known as: MTX (methotrexate)

Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors

Cyclosporin DRUG

Cyclosporin beginning day -4 and intravenous Methotrexate on days +1, +3, and +6 will be given

Also known as: CsA (Cyclosporin)

Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• PATIENTS:
• Patients with metastatic solid tumors ( breast, cholangiocarcinoma, small intestine/colon/rectal, adenocarcinoma, esophageal/gastric, hepatocellular, pancreatic, prostate, bony/soft tissue sarcomas, which are histologically confirmed, progressive and incurable.
• Due to low accrual, effective 12/19/2006, patients with adrenal, basal cell, transitional cell carcinoma of the bladder or uroepithelium, ovarian, small cell lung cancer, non small cell lung cancer, and adenocarcinomas of unknown primary origin are no longer eligible for the trial.
• Age greater than or equal to 10 to less than or equal to 80.
• No known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy.
• Metastatic disease, which is bi-dimensionally evaluable radiographically.
• No prior treatment for neoplasm within 30 days.
• Ability to comprehend the investigational nature of the study and provide informed consent.
• Availability of HLA identical or single HLA-locus mismatched family donor.
• Willingness and availability to return to the NIH for scheduled follow-ups.
• DONOR:
• HLA identical or single HLA-locus mismatched family donor
• Age greater than or equal to 10 up to 80 years old.
• Ability to comprehend the investigational nature of the study and provide informed consent.

You may not qualify if:

• PATIENT:
• Pregnant or lactating.
• Age less than 10 or greater than 80 years.
• ECOG performance status of 3 or more.
• Psychiatric disorder or mental deficiency severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
• Major anticipated illness or organ failure incompatible with survival from PBSC transplant.
• DLCO: less than 40% predicted.
• Left ventricular ejection fraction: less than 30%.
• Serum creatinine greater than 2.5mg/dl or creatinine clearance less than 50 cc/min by 24 hr urine collection.
• Serum bilirubin greater than 4 mg/dl
• Transaminases greater than 5 times the upper limit of normal.
• Oral intake less than 1,200 calories/day.
• Recent weight loss of greater than or equal to 10% of actual body weight.
• Life expectancy less than 3 months
• Therapy for malignancy within 4 weeks of beginning protocol.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Eibl B, Schwaighofer H, Nachbaur D, Marth C, Gachter A, Knapp R, Bock G, Gassner C, Schiller L, Petersen F, Niederwieser D. Evidence for a graft-versus-tumor effect in a patient treated with marrow ablative chemotherapy and allogeneic bone marrow transplantation for breast cancer. Blood. 1996 Aug 15;88(4):1501-8.

  PMID: 8695872 BACKGROUND

• Or R, Ackerstein A, Nagler A, Kapelushnik J, Naparstek E, Samuel S, Amar A, Bruatbar C, Slavin S. Allogeneic cell-mediated immunotherapy for breast cancer after autologous stem cell transplantation: a clinical pilot study. Cytokines Cell Mol Ther. 1998 Mar;4(1):1-6.

  PMID: 9557210 BACKGROUND

• Ueno NT, Rondon G, Mirza NQ, Geisler DK, Anderlini P, Giralt SA, Andersson BS, Claxton DF, Gajewski JL, Khouri IF, Korbling M, Mehra RC, Przepiorka D, Rahman Z, Samuels BI, van Besien K, Hortobagyi GN, Champlin RE. Allogeneic peripheral-blood progenitor-cell transplantation for poor-risk patients with metastatic breast cancer. J Clin Oncol. 1998 Mar;16(3):986-93. doi: 10.1200/JCO.1998.16.3.986.

  PMID: 9508181 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasm Metastasis; Graft vs Host Disease; Neoplasms

Interventions

Methotrexate; Cyclosporine

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Richard Childs, M.D. Principal Investigator, NIH, NHLBI
• Organization: National Heart Lung and Blood Institute (NHLBI)

childsr@nhlbi.nih.gov

301.451.7128

Study Officials

• Richard W Childs, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2006
• First Posted: November 4, 1999
• Study Start: March 12, 1999
• Primary Completion: August 14, 2008
• Study Completion: August 13, 2020
• Last Updated: November 10, 2021
• Results First Posted: November 10, 2021

Record last verified: 2020-08

Locations

US (1)