SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells (NCT04150042) | Clinical Trial Compass
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 range18 Years
SexALL
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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.
✓. Pancreatic ductal adenocarcinoma or pancreatic acinar cell carcinoma.
✓. If the potential subject has had surgical resection of the primary tumor, then there must be no evidence of disease progression between the time of surgical resection of the primary tumor and screening for enrollment if the patient is seeking enrollment in the immediate post-surgery period.
✓. Adenocarcinoma of the breast.
Exclusion criteria
✕. History of hypertensive crisis, hypertensive emergency, or malignant hypertension within the last year.
What they're measuring
1
Rate of Sinusoidal obstruction syndrome
Timeframe: 30 days after treatment
2
Rate of Idiopathic or Non-Infective Pulmonary Toxicity ≥ Grade 3
Timeframe: 3 months after the last treatment
3
Rate of Idiopathic or Non-Infective Pulmonary Toxicity ≥ Grade 3
Timeframe: 6 months after the last treatment
4
Rate of Presumptive Oxalate Nephropathy
Timeframe: Within 48 hours of vitamin C treatment
5
Rate of Cytokine Release Syndrome ≥ Grade 3
Timeframe: Within 48 hours of each vitamin C treatment
✕. Sustained or persistent systolic BP \> 165 mm Hg or diastolic \> 110 mm Hg.
✕. A past history of severe hypertension that is well-controlled with therapy or that was addressed by removal of the cause (e.g., removal of a medicine that caused the severe hypertension) is not an exclusion criterion.
✕. The presence of a pacemaker is not a contraindication and is not considered an exclusion criterion
✕. A volume ≥ 700 ml of normal liver received a dose ≥ 10 Gy.
✕. The mean dose to normal liver (i.e., liver minus gross tumor volume) was ≥ 10 Gy.
✕. The mean dose to normal lung (i.e., lung minus gross tumor volume) was ≥ 4 Gy.
9
Rate of Delayed Engraftment of Neutrophils
Timeframe: Day 21 after each treatment
10
Rate of Failed Engraftment of Neutrophils
Timeframe: Day 30 after each treatment
11
Rate of Delayed Engraftment of Platelets
Timeframe: Day 30 after each treatment
12
Overall incidence rate of adverse events
Timeframe: Until 12 months after the second stem cell treatment
13
Overall incidence rate of serious adverse events
Timeframe: Until 12 months after the second stem cell treatment
14
Overall incidence rate of Grade 3-5 adverse events
Timeframe: Until 12 months after the second stem cell treatment