Clinical trial

A Phase 2 Trial of Pharmacological Ascorbate With Concurrent Chemotherapy and Radiation Therapy for Non-small Cell Lung Cancer

Name

201712770

Description

This clinical trial evaluates adding high-dose ascorbate (vitamin C) to a standard therapy for non-small cell lung cancer. The standard therapy is radiation therapy combined with carboplatin and paclitaxel (types of chemotherapy). All subjects will receive high-dose ascorbate in addition to the standard therapy.

Trial arms

Trial start

2018-11-16

Estimated PCD

2025-12-01

Trial end

2027-12-31

Status

Recruiting

Phase

Early phase I

Treatment

Radiation Therapy

Conformal radiation administered daily, Monday through Friday Total dose is 60 Gray (Gy) and is delivered in 2 Gy fractions. One fraction is delivered daily for a total of 30 fractions in 30 days

Arms:

ChemoRT + Ascorbate

Other names:

external beam radiation therapy (EBRT), intensity modulated radiation therapy (IMRT), Volumetric Arc Therapy (VMAT), XRT

Paclitaxel

Administered intravenously (IV) Given the same day as carboplatin, but given before the carboplatin is administered * the dose is 45 mg/m2 (standard dose) * Administered weekly * 6 to 7 weeks of therapy, depending on when radiation starts * Standardized dose reductions are used

Arms:

ChemoRT + Ascorbate

Other names:

Nov-Onxol, Onxol, Paclitaxel Novaplus, Taxol

Carboplatin

Administered intravenously (IV) GIven the same day as paclitaxel, immediately after the paclitaxel infusion is done. * Prescribed at area-under-the-curve (AUC) = 2 using the Cockroft-Gault formula (standard) * Administered weekly * 6 to 7 weeks of therapy, depending on when radiation starts * Standard dose reductions are used

Arms:

ChemoRT + Ascorbate

Other names:

NovaPlus CARBOplatin, Amerinet Choice Carboplatin, Paraplatin, Paraplatin NovaPlus

Ascorbic Acid

Administered intravenously * 75 grams per infusion; each infusion is about 2 hours * 3 infusion per calendar week * The infusion is actively running for at least 20 minutes when radiation begins * May be given while chemotherapy is delayed due to low counts * Dose reductions are not used * Given for 6 to 7 weeks, depending on when radiation starts

Arms:

ChemoRT + Ascorbate

Other names:

Ascorbate, Vitamin C, Pharmacological ascorbate

Size

Primary endpoint

Progression rate at completion of radiation and chemotherapy

3 to 4 weeks after last radiation treatment

Eligibility criteria

Inclusion Criteria: Note: patients who have a small pleural effusion that is too small to safety tap and is not visible on a chest x-ray are still eligible * Pathologic diagnosis (i.e., cell sample, biopsy, tissue swap, bronchoscopy) of non-small cell lung cancer. * Recommended to receive carboplatin \& paclitaxel with radiation therapy as a treatment * Tumor or metastatic disease must measure at least 1 cm using a CT scan (CAT scan) * Physician determined the patient is healthy enough for chemotherapy and radiation therapy * At least part of the lung cancer must be viewable and measurable by CT or MRI * A platelet count of at least 100,000 cells per mililiter * A creatinine level of less than 1 1/2 times the upper limit of normal for the local lab test, or, a creatinine clearance of at least 60 mL/(min\*1.73m2) * Not pregnant, and commit to using birth control during the study Exclusion Criteria: * Exudative pleural effusion * Recurrent non-small cell lung cancer * Glucose-6-phosphate dehydrogenase (G6PD) deficiency * Patients actively receiving insulin or patients whose doctors have recommended current insulin use * Patients requiring daily finger-stick blood glucose measurements * Patients who are on the following drugs and cannot have a substitution or who decline the substitution: * warfarin * flecainide * methadone * amphetamines * quinidine * chlorpropamide * Prior radiation therapy that would result in a field overlap * Enrolled in another therapeutic clinical trial * Uncontrolled, intercurrent illness * Lactating women * HIV positive individuals undergoing therapy due to known drug:drug interaction between antiretroviral drugs and high-dose ascorbate therapy If all the above are met, the potential participant will receive a 15 gram challenge dose of ascorbate via intravenous infusion. This is the final screening procedure.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 46, 'type': 'ESTIMATED'}}

Updated at

2023-08-16

1 organization

2 products

2 drugs

4 indications

Organization

Joseph J. Cullen

Product

Radiation Therapy

Indication

cancer