Autologous Hematopoietic Stem Cells for Pancreatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pancreatic Cancer+14 MoreAutologous Hematopoietic Stem Cells - Device
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new treatment for pancreatic cancer in patients with an inherited BRCA1 or BRCA2 mutation. The treatment involves a combination of drugs given through an IV, with the goal of determining if it is safe.

Eligible Conditions
  • Pancreatic Cancer
  • Metastatic Breast Cancer
  • Breast Cancer Stage IV
  • Stage IV Pancreatic Cancer
  • HER2-negative Breast Cancer
  • HER2 Negative Breast Cancer
  • Breast Cancer
  • PALB2 Gene Mutation
  • Pancreatic Acinar Cell Carcinoma
  • Pancreatic Cancer Metastatic
  • BRCA2 Gene Mutation
  • BRCA1 Mutations

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

11 Primary · 4 Secondary · Reporting Duration: Within 48 hours of vitamin C treatment

Month 12
Objective response according to RECIST version 1.1
Objective response rate in metastatic lesions
30 days after treatment
Rate of Sinusoidal obstruction syndrome
Month 6
Rate of Idiopathic or Non-Infective Pulmonary Toxicity
Day 21
Rate of Delayed Engraftment of Neutrophils
Inflammatory disease of mucous membrane
Rate of Mucositis ≥ Grade 3
Day 30
Rate of Delayed Engraftment of Platelets
Rate of Failed Engraftment of Neutrophils
First day of chemotherapy
Area Under the Concentration-Time Curve for Melphalan
Clearance of Melphalan
Distribution-Phase Half-Life of Melphalan
Elimination-Phase Half-Life of Melphalan
Maximum Plasma Concentration of Melphalan
Volume of Distribution of Melphalan
Month 12
Overall Survival
Overall incidence rate of Grade 3-5 adverse events
Overall incidence rate of adverse events
Overall incidence rate of serious adverse events
Progression-Free Survival
Hour 48
Rate of Presumptive Oxalate Nephropathy

Trial Safety

Safety Progress

1 of 3

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Trial Design

1 Treatment Group

Chemotherapy/stem cell treatment
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Autologous Hematopoietic Stem Cells · No Placebo Group · Phase 1

Chemotherapy/stem cell treatmentExperimental Group · 6 Interventions: Melphalan, Autologous Hematopoietic Stem Cells, BCNU, Vitamin B12B, Vitamin C, Ethanol · Intervention Types: Drug, Device, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
FDA approved
Carmustine
FDA approved
Ascorbic acid
FDA approved
Ethanol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 48 hours of vitamin c treatment

Who is running the clinical trial?

Myriad Genetics, Inc.Industry Sponsor
15 Previous Clinical Trials
5,342 Total Patients Enrolled
General Oncology, Inc.Lead Sponsor
Kenneth H Yu, M.D.Principal InvestigatorMemorial Sloan Kettering Cancer Center
Colin D Weekes, M.D., Ph.D.Principal InvestigatorMassachusetts General Hospital

Eligibility Criteria

Age 18 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a complete response from prior chemotherapy.
You have been expected to live for 6 months or more.
You have a prior history of surgery or ablation of the primary tumor.
You are post-surgical and your wounds are healed and significant complications resolved.

Who else is applying?

What state do they live in?
Kentucky100.0%
How old are they?
65+100.0%
What site did they apply to?
Massachusetts General Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Email100.0%
Most responsive sites:
  1. Massachusetts General Hospital: < 24 hours