SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
General Oncology, Inc.
Study ID
NCT04150042
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Adenocarcinoma of the Breast
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Breast Cancer Metastatic
  • Breast Cancer Stage IV
  • HER2 Negative Breast Carcinoma
  • HER2-negative Breast Cancer
  • Metastatic Pancreatic Cancer
  • Metastatic Pancreatic Ductal Adenocarcinoma
  • PALB2 Gene Mutation
  • Pancreas Cancer
  • Pancreas Cancer, Metastatic
  • Pancreas Cancer, Recurrent
  • Pancreatic Acinar Cell Carcinoma
  • Pancreatic Adenocarcinoma Metastatic
  • Pancreatic Cancer
  • Pancreatic Cancer Stage IV
  • Pancreatic Ductal Adenocarcinoma
  • Stage 4 Pancreatic Cancer
  • Stage IV Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Melphalan — DRUG
    Intravenous melphalan (to be given in conjunction with the other listed drugs).
  • BCNU — DRUG
    Intravenous BCNU (to be given in conjunction with the other listed drugs).
  • Vitamin B12B — DRUG
    Intravenous vitamin B12b (to be given in conjunction with the other listed drugs).
  • Vitamin C — DRUG
    Intravenous vitamin C (to be given in conjunction with the other listed drugs).
  • Autologous Hematopoietic Stem Cells — DEVICE
    After each cycle of chemotherapy, participants will receive an autologous hematopoietic stem cell infusion.

Study Details

The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, vitamin B12b, and vitamin C with autologous hematopoietic stem cell infusion. A dose-escalation schedule is being employed for the vitamin C.

Key Dates

Start date
Jan 13, 2021
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy/stem cell treatment

Primary Outcome Measure

Rate of Sinusoidal obstruction syndrome [ Time Frame: 30 days after treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Kenneth H Yu, M.D.
Kenneth H Yu, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Massachusetts General Hospital· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NY

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