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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014