Cyclophosphamide and Pulse Dexamethasone With Rapamycin or Hydroxychloroquine

NCT01396200 | Completed Early Phase 1 DMC

• 1 other identifier: UPCC 09411
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the feasibility of giving (i) rapamycin or (ii) hydroxychloroquine (HCQ), with standard doses of infusional cyclophosphamide and pulse dexamethasone (cy/dex) for patients with relapsed/refractory multiple myeloma, as well as the feasibility of obtaining multiple blood and bone marrow samples during treatment to assess the pharmacodynamic effects of the treatment.

Conditions

Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events

  The feasibility of administering rapamycin and hydroxychloroquine (HCQ), with standard doses of infusional cyclophosphamide and pulse dexamethasone (cy/dex) for patients with relapsed/refractory multiple myeloma.

Secondary Outcomes (1)

• Toxicities and response to the regimen

Study Arms (2)

Hydroxychloroquine (Cohort B)

EXPERIMENTAL

Infusional cyclophosphamide 300mg/m2/day for 4 days IV and dexamethasone 40mg/day orally or IV for 4 days on days 1 through 4. Hydroxychloroquine oral will be given on days 5 through 28 of cycle 1 and every day of all subsequent cycles (to be given with milk or food at approximately the same time each day)

Drug: Hydroxychloroquine

Rapamycin (Cohort A)

EXPERIMENTAL

Infusional cyclophosphamide 300 mg/m2/day for 4 days IV and dexamethasone 40 mg/day orally or IV for 4 days on days 3 through 6. Rapamycin oral loading dose will be given on day 1 followed by an oral daily dose for an additional 5 days (days 2 through 6) to be given on an empty stomach at approximately the same time each day suggested 11 am)This dosing schedule is the same for all cycles.

Drug: Rapamycin

Interventions

Hydroxychloroquine DRUG

Dose level 1: 800mg by mouth daily Dose level -1: 600 mg by mouth daily

Hydroxychloroquine (Cohort B)

Rapamycin DRUG

Dose level 1: Loading dose 12mg, daily dose 4mg Dose level -1: Loading dose 9mg,daily dose 3mg

Rapamycin (Cohort A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each subject must meet ALL of the following criteria during screening to be enrolled:
• Histologically confirmed multiple myeloma
• Documented relapse or persistent disease after at least one prior therapy (which may include autologous and allogeneic bone marrow transplantation)
• Need for further therapy for myeloma, as determined by the patients treating physician
• Age 18 years
• ECOG PS 0-2

You may not qualify if:

• History of allergic reactions to compounds of similar chemical or biological composition to rapamycin or hydroxychloroquine
• Patients may not take any of the following medications while on study (in the rapamycin arms only), but will be considered eligible if medication is discontinued 72 hrs prior to first dose of Rapamycin:
• Carbamazepine (e.g. Tegretol)
• Rifabutin (e.g. Mycobutin)
• Rifampin (e.g. Rifadin)
• Rifapentine (e.g. Priftin)
• St. Johns Wort Clarithromycin (e.g. Biaxin)
• Cyclosporin e.g. (Neorla or Sandimmune)
• Diltiazem (e.g. Cardizem)
• Erythromycin (e.g. Akne-Mycin, Ery-Tab)
• Itraconazole (e.g. Sporonox)
• Fluconazole (e.g. Diflucan)
• Ketoconazole (e.g. Nizoral)
• Telithromycin (e.g. Ketek)
• Verapamil (e.g. Calan SR, Isoptin, Verelan)

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Interventions

Hydroxychloroquine; Sirolimus

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Lactones; Organic Chemicals

Study Officials

• Dan Vogl, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 18, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

US (1)