Experimental combo aims to overcome drug resistance in metastatic cancers

NCT ID NCT04150042

Recruiting now Disease control Sponsor: General Oncology, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing a combination of two chemotherapy drugs (melphalan and BCNU) plus vitamins B12b and C, followed by an infusion of the patient's own stem cells. The goal is to see if this approach is safe for people with metastatic pancreatic or breast cancer, especially those with BRCA or PALB2 mutations. The study involves 24 participants and uses a dose-escalation plan for vitamin C to find the safest dose.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Melphalan, BCNU (carmustine), vitamin B12b (hydroxocobalamin), vitamin C (ascorbic acid), and autologous hematopoietic stem cells
What this could lead to: If this trial shows safety, it could point toward a new treatment option for people with metastatic pancreatic or breast cancer who have specific genetic mutations.
What could go wrong: This is a very early phase 1 trial with only 24 participants, focused on safety, not effectiveness. The treatment involves strong chemotherapy with serious risks like liver damage, lung problems, and kidney injury.

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Conditions

The condition(s) this trial relates to.

BRCA1-related cancer predisposition BRCA2-related cancer predisposition breast adenocarcinoma breast cancer breast neoplasm exocrine pancreatic carcinoma Her2-receptor negative breast cancer malignant pancreatic neoplasm Neoplasm Metastasis PALB2-related cancer predisposition pancreatic acinar cell carcinoma pancreatic adenocarcinoma pancreatic ductal adenocarcinoma pancreatic neoplasm Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADENOCARCINOMA OF THE BREAST BRCA1 MUTATION BRCA2 MUTATION BREAST CANCER STAGE IV BREAST CANCER, METASTATIC HER2-NEGATIVE BREAST CANCER HER2-NEGATIVE BREAST CARCINOMA 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

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

Massachusetts General Hospital
COMPLETED

Boston, Massachusetts, 02114, United States
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States

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