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Phase II Trial of High Dose Intravenous Vitamin C in Patients With Refractory Non-Hodgkin Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin Lymphoma

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Trial Information

Phase II Trial of High Dose Intravenous Vitamin C in Patients With Refractory Non-Hodgkin Lymphoma


Inclusion Criteria:



- Age greater than 18 years old

- Aggressive or very aggressive NHL

- Failed one or more therapies

- Patients must not have progressed within 60 days of last therapy

- Not received allogeneic stem cell transplant

- No reasonable standard therapeutic options available

- Glucose 6 phosphate dehydrogenase status normal

- ECOG performance status 0-2

- Normal creatinine and transaminase

- Women of child-bearing potential confirm negative pregnancy test

Exclusion Criteria:

- Significant co-morbid disorders

- Significant psychiatric symptoms

- Smoking

- Excessive alcohol or drug use

- Enrollment in other experimental therapy

- Active infection

- Patients experiencing ongoing response to recent treatments

- Patients who have received chemotherapy within 30 days or biological therapy within 6
weeks

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

10 weeks

Safety Issue:

No

Principal Investigator

Daniel Monti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Faculty Member

Authority:

United States: Food and Drug Administration

Study ID:

IND-77486

NCT ID:

NCT00626444

Start Date:

February 2008

Completion Date:

December 2011

Related Keywords:

  • Non-Hodgkin Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Jefferson-Myrna Brind Center of Integrative MedicinePhiladelphia, Pennsylvania  19107