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

ConditionsPancreatic Adenocarcinoma MetastaticBRCA1 MutationBRCA2 MutationPancreatic Acinar Cell CarcinomaPancreatic Ductal AdenocarcinomaPancreatic CancerMetastatic Pancreatic CancerMetastatic Pancreatic Ductal AdenocarcinomaBreast Cancer MetastaticBreast Cancer Stage IVPancreatic Cancer Stage IVHER2-negative Breast CancerHER2 Negative Breast CarcinomaAdenocarcinoma of the BreastPALB2 Gene MutationPancreas Cancer, MetastaticPancreas Cancer, RecurrentPancreas CancerStage IV Pancreatic CancerStage 4 Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral Oncology, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Pancreatic or breast cancer, as described below.

Stage IV (based on AJCC staging guidelines) at the time of enrollment.

Expected survival time ≥ 6 months, as determined by the investigator.

Disqualifiers

Rapid disease progression or clinical features concerning for onset of rapid symptomatic deterioration, as determined by the investigator.

Biliary tract obstruction.

Current cholangitis. A biliary stent in situ does not otherwise exclude protocol participation.

A history of only one episode of cholangitis and fewer than 30 days have passed since discontinuation of antibiotic treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Chemotherapy/stem cell treatmentExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Rate of Sinusoidal obstruction syndrome

Sinusoidal obstruction syndrome diagnosis and grading will use the European Society for Blood and Marrow Transplantation's Revised Diagnosis and Severity Criteria for Sinusoidal Obstruction Syndrome/Veno-Occlusive Disease in Adult Patients as published in 2016. Gradings are from mild to very severe (multi-organ dysfunction/multi-organ failure).

Time frame
30 days after treatment
2

Rate of Idiopathic or Non-Infective Pulmonary Toxicity ≥ Grade 3

The American Thoracic Society Committee on Idiopathic Pneumonia Syndrome definition will be employed.

Time frame
3 months after the last treatment
3

Rate of Idiopathic or Non-Infective Pulmonary Toxicity ≥ Grade 3

The American Thoracic Society Committee on Idiopathic Pneumonia Syndrome definition will be employed.

Time frame
6 months after the last treatment
4

Rate of Presumptive Oxalate Nephropathy

Oxalate nephropathy will be presumed if there is acute kidney injury or increased creatinine, grade 3 or higher by the criteria of CTCAE Version 5.0 within 48 h of the administration of vitamin C, in the absence of a clear alternative explanation (an example of an alternative explanation is tumor lysis syndrome).

Time frame
Within 48 hours of vitamin C treatment

Secondary outcomes

1

Objective response according to RECIST version 1.1

Objective response will be evaluated according to RECIST version 1.1 as assessed by the independent core imaging facility. This endpoint will be evaluated with CT scans with contrast of the abdomen, pelvis, and chest and other sites as clinically indicated at each time point.

Time frame
1 month after the first stem cell treatment
2

Objective response according to RECIST version 1.1

Objective response will be evaluated according to RECIST version 1.1 as assessed by the independent core imaging facility. This endpoint will be evaluated with CT scans with contrast of the abdomen, pelvis, and chest and other sites as clinically indicated at each time point.

Time frame
1 month after the second stem cell treatment
3

Objective response according to RECIST version 1.1

Objective response will be evaluated according to RECIST version 1.1 as assessed by the independent core imaging facility. This endpoint will be evaluated with CT scans with contrast of the abdomen, pelvis, and chest and other sites as clinically indicated at each time point.

Time frame
3 months after the second stem cell treatment
4

Objective response according to RECIST version 1.1

Objective response will be evaluated according to RECIST version 1.1 as assessed by the independent core imaging facility. This endpoint will be evaluated with CT scans with contrast of the abdomen, pelvis, and chest and other sites as clinically indicated at each time point.

Time frame
6 months after the second stem cell treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

General Oncology, Inc.

Lead sponsor

Myriad Genetics, Inc.

Collaborator

Source ClinicalTrials.gov
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