RecruitingPhase 1

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

United States24 participantsStarted 2021-01-13

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The mutation must be a known or suspected deleterious mutation as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.
. There must be biallelic loss or inactivation of the mutated BRCA1, BRCA2, or PALB2 gene as assessed by a CLIA-certified laboratory.
. The Genetics Review Committee for this trial, which is comprised of a core group of investigators and whose actions are performed in accordance with the committee's charter, must agree that the biallelic mutations are deleterious or suspected deleterious.
. Subject must have received at least 16 weeks of first-line (platinum-based\*) chemotherapy with no evidence of treatment failure, where treatment failure is defined as growing tumors, new lesions, or a steadily rising tumor marker during or within eight weeks of completion of the first line therapy.
. \* Subjects can also have been treated with FOLFIRINOX but switched to FOLFIRI due to oxaliplatin side effects.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of Sinusoidal obstruction syndrome

Timeframe: 30 days after treatment

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

Timeframe: 3 months after the last treatment

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

Timeframe: 6 months after the last treatment

Rate of Presumptive Oxalate Nephropathy

Timeframe: Within 48 hours of vitamin C treatment

Rate of Cytokine Release Syndrome ≥ Grade 3

Timeframe: Within 48 hours of each vitamin C treatment

Rate of Mucositis ≥ Grade 3

Timeframe: Day 7 after each treatment

Rate of Mucositis ≥ Grade 3

Timeframe: Day 14 after each treatment

Trial details

NCT IDNCT04150042

SponsorGeneral Oncology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

General Oncology (study sponsor)

818-4-SHARON (818-474-2766) contact@SharonTrial.com

View on ClinicalTrials.gov More Pancreatic Adenocarcinoma Metastatic trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The mutation must be a known or suspected deleterious mutation as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.
. There must be biallelic loss or inactivation of the mutated BRCA1, BRCA2, or PALB2 gene as assessed by a CLIA-certified laboratory.
. The Genetics Review Committee for this trial, which is comprised of a core group of investigators and whose actions are performed in accordance with the committee's charter, must agree that the biallelic mutations are deleterious or suspected deleterious.
. Subject must have received at least 16 weeks of first-line (platinum-based\*) chemotherapy with no evidence of treatment failure, where treatment failure is defined as growing tumors, new lesions, or a steadily rising tumor marker during or within eight weeks of completion of the first line therapy.
. \* Subjects can also have been treated with FOLFIRINOX but switched to FOLFIRI due to oxaliplatin side effects.

What they're measuring

Rate of Sinusoidal obstruction syndrome

Timeframe: 30 days after treatment

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

Timeframe: 3 months after the last treatment

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

Timeframe: 6 months after the last treatment

Rate of Presumptive Oxalate Nephropathy

Timeframe: Within 48 hours of vitamin C treatment

Rate of Cytokine Release Syndrome ≥ Grade 3

Timeframe: Within 48 hours of each vitamin C treatment

Rate of Mucositis ≥ Grade 3

Timeframe: Day 7 after each treatment

Rate of Mucositis ≥ Grade 3

Timeframe: Day 14 after each treatment

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria