Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Trastuzumab

Immunoglobulins

Mitogens

Vinca Alkaloids

Antineoplastic Agents, Immunological

Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes, repeated every 21 days

Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2.

Vinflunine

Denise A Yardley, MD

This research study involves the anti-cancer medication trastuzumab and the investigational drug vinflunine. The purpose of this trials is to see if trastuzumab and vinflunine used in combination or vinflunine alone is effective in the treatment of metastatic breast cancer

If the tumor is HER2neu positive, eligible patients will receive trastuzumab and vinflunine intravenously (IV) every 3 weeks.

If the tumor is HER2neu negative, eligible patients will receive vinflunine intravenously (IV) every 3 weeks.

Patients whose cancer does not grow or decreases in size may continue to receive treatment until cancer progression. Evaluation of cancer will be every 9 weeks.

Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer

Phase II Trial of Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Bristol-Myers Squibb

SCRI Development Innovations, LLC

Vinflunine/Trastuzumab

Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days

Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2

Total

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

John D. Hainsworth, MD

Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Overall Study

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Vincristine

Tubulin Modulators

Antimitotic Agents

Single Arm study: Vincristine 2mg administered IV by infusion over 5 minutes.

Vincristine 2mg will be administered one time to participants. Blood samples will be collected pre and post dose.

vincristine

Alexey V Danilov, MD

In this proof-of-principle study, patients with chronic lymphocytic leukemia (CLL), who are scheduled to initiate treatment per the recommendations of their primary oncologist, will receive a single dose of vincristine 2 milligrams (mg). The objective is to determine if this single dose will induce rapid cell death in isolated CLL cells.

Vincristine 2 mg will be administered to the participants intravenously over 5 minutes. Blood samples will be collected from an intravenous line inserted into the contralateral limb to that where the vincristine was given, at time zero (pre-vincristine treatment), immediately after vincristine administration (within 2-10 minutes upon completion of administration) and at 1, 2, 4 and 6 hours post-vincristine treatment. Patients will then at a later date receive chemotherapy treatment as prescribed by their primary oncologist.

Within 7 days of vincristine administration, participants will receive a phone call from the research nurse to discuss potential toxicities. At the time of the initiation of standard chemotherapy treatment, the Principal Investigator will also meet with the participant to collect information regarding adverse events.

A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation in Patients With Chronic Lymphocytic Leukemia (CLL)

A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation Status in Patients With Chronic Lymphocytic Leukemia (CLL)

blood draws are collected pre-vincristine and at 10 minutes,1,2,4,and 6 hours post vincristine.

Dartmouth-Hitchcock Medical Center

Pain

Micronutrients

Hematinics

Vitamins

Vinorelbine

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Cisplatin

Oxaliplatin

Vitamin B 6

Pyridoxal

Pyridoxine

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Taxane

Folic Acid

Trace Elements

Vitamin B6

Methylcobalamin

Vitamin B12

Cobalamin

Cyanocobalamin

Folate

Vitamin B9

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

Multivitamin (MV)

Multivitamin (containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12), plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6

Patients are treated per standard of care according to the choice of the treating physician with heavy metals (cisplatin, oxaliplatin), taxanes (paclitaxel, docetaxel), or vinca alkaloids (vincristine, vinorelbine)

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; vincristine, 8-16; vinorelbine, 360-480; cisplatin, 240-400; oxaliplatin, 400-800; abraxane, 1200-1800

Chemotherapy

Zoneddy Dayao, MD

Many types of chemotherapy may cause nerve damage as a side effect. This neurotoxicity can manifest as peripheral sensory neuropathy (characterized by numbness, tingling, or pain). The goal of this study is to determine the efficacy of the combination of vitamin B6 and B12 in preventing chemotherapy induced neuropathy.

Neuropathy can be a significant side effect of chemotherapy using platinum compounds, taxanes, and vinca alkaloids. There is clinical and preclinical data that vitamin B6 and B12 may alleviate neuropathy in experimentally induced neuropathy in animal models, or clinical neuropathy such as diabetic neuropathy. This is a randomized phase III study of the use of multivitamins with or without vitamin B6 and B12 to prevent or relieve neuropathic toxicity from chemotherapy in patients receiving chemotherapy. Patients will be stratified by type of chemotherapy agent (3 groups), presence or absence of neuropathy at baseline, and randomized to receive placebo or vitamin B6/B12 supplementation.

A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients

A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients.

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported.

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported.

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported.

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients.

New Mexico Cancer Care Alliance

Since vitamin B6 and B12 are food supplements with only rare toxic effects, no toxicity will be recorded. Only serious adverse (SAE) will be reported, whether or not related to these vitamins.

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Cumulative doses (in mg/m2) are:

paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400

Age, Continuous

The number of completed surveys decreased as time went on for each group of patients. This resulted in small numbers of patients to analyze, especially in Group 3 (Vinca Alkaloids), since there weren't many patients in this group to begin with.

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800

Taxane Group: Multivitamin (MV) Arm

Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400

Taxane Group: MV + Vitamin B12 + Vitamin B6

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Cumulative doses for chemotherapy (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

Heavy Metals Group: Multivitamin (MV) Arm

Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Ranges of cumulative doses (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Cumulative doses for chemotherapy (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Vinca Alkaloids Group: Multivitamin (MV) Arm

Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Ranges of cumulative doses (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm

Of the 92 and 97 patients in the MV arm and MV + Vit.B12 + VitB6 arm, 84 and 86 patients, respectively, in the Group 1 (Taxanes) completed the FACT-Tax questionnaire at baseline and the analysis is presented here. This also applies to 48 and 45 patients in Group 2 (Heavy Metals) and 10 and 12 patients in Group 3 (Vincas)

Neurotoxicity Assessment at Baseline

Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Ranges of cumulative doses (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Ranges of cumulative doses (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Of the 92 \& 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 72 \& 80 patients, respectively, in the Group 1 (Taxanes) both completed 2 cycles of treatment and completed the FACT-Tax questionnaire at cycle 2, and the analysis is presented here. The same applies to 27 \& 25 patients in Group 2 (Heavy Metals) and 9 \& 10 patients in Group 3 (Vinca)

Neurotoxicity Assessment at Cycle 2

Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800

Of the 92 \& 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 57 \& 65 patients, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemotherapy and completed the FACT-Tax questionnaire at cycle 4, and the analysis is presented here. The same applies to 28 \& 21 patients in Group 2 (Heavy Metals) and 6 \& 9 patients in Group 3 (Vinca)

Neurotoxicity Assessment at Cycle 4

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, abraxane, 1200-1800

Of the 92 \& 97 patients in the Multivitamin (MV) and MV + Vit.B12 + VitB6 arms, 54 \& 62, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemo and the FACT-Tax questionnaire at baseline and cycle 4; analysis is presented here. The same applies to 28 \& 20 patients in Group 2 (Heavy Metals) and 5 \& 9 patients in Group 3 (Vinca)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer	NCT00284180	Breast Neoplasm... Breast Cancer	Vinflunine Trastuzumab	18 Years -	SCRI Development Innovations, LLC
A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation in Patients With Chronic Lymphocytic Leukemia (CLL)	NCT01463852	Chronic Lymphoc...	vincristine	18 Years -	Dartmouth-Hitchcock Medical Center
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients	NCT00659269	Cancer	Multivitamin (M... Multivitamin + ... Chemotherapy	18 Years -	New Mexico Cancer Care Alliance
Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer	NCT00284180	Breast Neoplasm... Breast Cancer	Vinflunine Trastuzumab	18 Years -	SCRI Development Innovations, LLC

Spots Global Cancer Trial Database for vinca alkaloid