Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01789723
First received: February 7, 2013
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.


Condition Intervention Phase
Non Hodgkin's Lymphoma
Drug: Fusilev
Drug: Folotyn
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open Label, Multicenter, Dose Finding, Phase 1 Study of Fusilev® (Levoleucovorin) to Prevent or Reduce Mucositis in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Receiving Folotyn® (Pralatrexate)

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Optimal dose and schedule of Fusilev to prevent or reduce mucositis [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
    The patient will be seen in the clinic for an oral mucositis assessment at baseline. During the 6 weeks of Folotyn treatment, oral mucositis assessment will be performed weekly prior to each Folotyn dose and again on Day 4 (prior to the Fusilev dose when applicable) by a qualified health care professional. Patients will complete an Oral Mucositis Daily Questionnaire (OMQD) starting at Day 1 of Week 1 and ending at the End of Treatment Visit.


Secondary Outcome Measures:
  • Impact of Fusilev on Folotyn related Oral Mucositis [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
    To determine the impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis To determine the impact of Fusilev on the frequency of Folotyn-related oral mucositis To determine the impact of Fusilev on the number of Folotyn doses delivered

  • Relationship between Fusilev use and oral mucositis [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
    To determine the relationship between Fusilev use and oral mucositis as a function of the pretreatment homocysteine (HCY) and methylmalonic acid (MMA) levels


Other Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
    To determine overall response rate (ORR) of Folotyn in relapsed or refractory Non-Hodgkin's lymphoma other than PTCL


Enrollment: 0
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Fusilev - 10 doses

Fusilev: 5 mg/m2 QID, starting on Day 2 (24 ± 3 hours after Folotyn dose) for a total of 10 doses Day 2: 4 doses Day 3: 4 doses Day 4: 2 doses.

Folotyn: 30 mg/m2 once weekly for 6 weeks

Drug: Fusilev
Fusilev will be administered by IV push (3-5 minutes) at a dose of 5 mg/m2. Fusilev administration, QID or BID will start 24 ± 3 hours after Folotyn administration depending on the dose cohort.
Other Name: Fusilev - (Levoleucovorin)
Drug: Folotyn
A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
Other Name: Folotyn - (Pralatrexate)
Experimental: Cohort 2: Fusilev - 6 doses

Fusilev: 5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose), 3, and 4.

Folotyn: 30 mg/m2 once weekly for 6 weeks

Drug: Fusilev
Fusilev will be administered by IV push (3-5 minutes) at a dose of 5 mg/m2. Fusilev administration, QID or BID will start 24 ± 3 hours after Folotyn administration depending on the dose cohort.
Other Name: Fusilev - (Levoleucovorin)
Drug: Folotyn
A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
Other Name: Folotyn - (Pralatrexate)
Experimental: Cohort 3: Fusilev - 4 doses

5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose) and 3.

Folotyn: 30 mg/m2 once weekly for 6 weeks

Drug: Fusilev
Fusilev will be administered by IV push (3-5 minutes) at a dose of 5 mg/m2. Fusilev administration, QID or BID will start 24 ± 3 hours after Folotyn administration depending on the dose cohort.
Other Name: Fusilev - (Levoleucovorin)
Drug: Folotyn
A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
Other Name: Folotyn - (Pralatrexate)
Experimental: Cohort 4: Fusilev - 2 doses

5 mg/m2 BID, on Day 2 (24 ± 3 hours after Folotyn dose.

Folotyn: 30 mg/m2 once weekly for 6 weeks

Drug: Fusilev
Fusilev will be administered by IV push (3-5 minutes) at a dose of 5 mg/m2. Fusilev administration, QID or BID will start 24 ± 3 hours after Folotyn administration depending on the dose cohort.
Other Name: Fusilev - (Levoleucovorin)
Drug: Folotyn
A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
Other Name: Folotyn - (Pralatrexate)
Experimental: Cohort 5: Fusilev - 1 dose

Fusilev: 5 mg/m2 once on Day 2.

Folotyn: 30 mg/m2 once weekly for 6 weeks

Drug: Fusilev
Fusilev will be administered by IV push (3-5 minutes) at a dose of 5 mg/m2. Fusilev administration, QID or BID will start 24 ± 3 hours after Folotyn administration depending on the dose cohort.
Other Name: Fusilev - (Levoleucovorin)
Drug: Folotyn
A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
Other Name: Folotyn - (Pralatrexate)

Detailed Description:

This is an open label, uncontrolled, nonrandomized, multicenter, dose finding, Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral Mucositis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Patients with relapsed or refractory NHL who are eligible for Folotyn treatment. Patient has histologically/cytologically confirmed, measurable (lesion or node ≥ 2 cm by computed tomography [CT]
  • Progressive disease or persistent disease after at least 1 prior treatment
  • ECOG performance status ≤ 2
  • Adequate hematological, hepatic, and renal function

Exclusion Criteria:

  • Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix)
  • Congestive heart failure
  • Uncontrolled hypertension
  • Known human immunodeficiency virus (HIV)-positive diagnosis
  • Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
  • Major surgery within 14 days of enrollment
  • Pregnant or breast-feeding women
  • Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
  • Previous exposure to pralatrexate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789723

Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Principal Investigator: Ahmed Sawas, MD Columbia University
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01789723     History of Changes
Other Study ID Numbers: SPI-FUS-12-102
Study First Received: February 7, 2013
Last Updated: July 23, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Mucositis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Leucovorin
Levoleucovorin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on April 14, 2014