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Protocol # 21-609

Status

Recruiting

Description

The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on pancreatic cancer in patients who have an inherited, deleterious BRCA1 or BRCA2 genetic alteration. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, low-dose I.V. ethanol, vitamin B12b, and vitamin C in association with autologous hematopoietic stem cell infusion. A dose-escalation schedule will be employed for vitamin C

Condition

  • Pancreatic Adenocarcinoma Metastatic
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Pancreatic Acinar Cell Carcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Cancer
  • Metastatic Pancreatic Cancer
  • Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

  • Melphalan
  • BCNU
  • Vitamin B12B
  • Vitamin C
  • Ethanol
  • Autologous Hematopoietic Stem Cells

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Rate of Sinusoidal obstruction syndrome
  • Rate of Idiopathic or Non-Infective Pulmonary Toxicity
  • Rate of Idiopathic or Non-Infective Pulmonary Toxicity
  • Rate of Presumptive Oxalate Nephropathy
  • Rate of Mucositis
  • Rate of Mucositis
  • Rate of Mucositis
  • Rate of Delayed Engraftment of Neutrophils
  • Rate of Failed Engraftment of Neutrophils
  • Rate of Delayed Engraftment of Platelets
  • Overall incidence rate of adverse events
  • Overall incidence rate of serious adverse events
  • Overall incidence rate of Grade 3-5 adverse events

Secondary Outcome:

  • Objective response according to RECIST version 1.1
  • Objective response according to RECIST version 1.1
  • Objective response according to RECIST version 1.1
  • Objective response according to RECIST version 1.1
  • Objective response according to RECIST version 1.1
  • Objective response according to RECIST version 1.1
  • Objective response rate in metastatic lesions
  • Objective response rate in metastatic lesions
  • Objective response rate in metastatic lesions
  • Objective response rate in metastatic lesions
  • Objective response rate in metastatic lesions
  • Objective response rate in metastatic lesions
  • Overall Survival
  • Progression-Free Survival

Enrollment

10

Study Start Date

January 13, 2021

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

General Oncology, Inc.

Source

General Oncology, Inc.

Official title

A Phase 1 Trial of Melphalan, BCNU, Hydroxocobalamin, Ascorbic Acid, and Autologous Bone Marrow Stem Cell Infusion in Patients With Pancreatic Cancer and an Inherited BRCA1 or BRCA2 Mutation

Clinicaltrials.gov Identifier

NCT04150042

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.