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Hexalen (Altretamine) - Summary

 
 



WARNINGS

  1. HEXALEN® capsules should only be given under the supervision of a physician experienced in the use of antineoplastic agents.
  2. Peripheral blood counts should be monitored at least monthly, prior to the initiation of each course of HEXALEN® capsules, and as clinically indicated (see Adverse Reactions).
  3. Because of the possibility of HEXALEN® capsules-related neurotoxicity, neurologic examination should be performed regularly during HEXALEN® capsules administration (see Adverse Reactions).
 

HEXALEN SUMMARY

HEXALEN®
(ALTRETAMINE) CAPSULES

50 mg
RX Only

HEXALEN® (altretamine) capsules, is a synthetic cytotoxic antineoplastic s-triazine derivative. HEXALEN® capsules contain 50 mg of altretamine for oral administration. Inert ingredients include lactose, anhydrous and calcium stearate.

HEXALEN® (altretamine) capsules is indicated for use as a single agent in the palliative treatment of patients with persistent or recurrent ovarian cancer following first-line therapy with a cisplatin and/or alkylating agent-based combination.


See all Hexalen indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Hexalen (Altretamine)

Beta-Blockers: Evidence of Mortality Benefit in Ovarian Cancer (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.28]
(MedPage Today) -- Survival more than doubled in patients receiving agents like propranolol

Blood Pressure Drugs Linked to Longer Ovarian Cancer Survival
Source: MedicineNet Clinical Trials Specialty [2015.08.25]
Title: Blood Pressure Drugs Linked to Longer Ovarian Cancer Survival
Category: Health News
Created: 8/24/2015 12:00:00 AM
Last Editorial Review: 8/25/2015 12:00:00 AM

Beta-blocker Use Linked to Improved Ovarian Cancer Survival
Source: Medscape Hematology-Oncology Headlines [2015.08.24]
In a large, retrospective study of women with ovarian cancer, use of nonselective beta-blockers was associated with longer survival than nonuse.
Medscape Medical News

Multigene panel testing for hereditary breast/ovarian cancer risk assessment
Source: Breast Cancer News From Medical News Today [2015.08.19]
Multigene testing of women negative for BRCA1 and BRCA2 found some of them harbored other harmful genetic mutations, most commonly moderate-risk breast and ovarian cancer genes and Lynch syndrome...

Study of multi gene panel shows heredity risk of breast and ovarian cancer
Source: Breast Cancer News From Medical News Today [2015.08.17]
Invitae Corporation, a genetic information company, and its collaborators have announced the publication of new data describing the clinical actionability of multi-gene testing for hereditary...

more news >>

Published Studies Related to Hexalen (Altretamine)

The bioavailability of three altretamine formulations. [1989.12.15]
The bioavailability of two altretamine preparations was studied in a randomized cross-over design. The two preparations were compared with a third in a parallel design... The in vivo data showed a trend to differences in bioavailability.

Synergy of irofulven in combination with other DNA damaging agents: synergistic interaction with altretamine, alkylating, and platinum-derived agents in the MV522 lung tumor model. [2008.12]
PURPOSE: Irofulven (MGI 114, NSC 683863) is a semisynthetic derivative of illudin S, a natural product present in the Omphalotus illudins (Jack O'Lantern) mushroom. This novel agent produces DNA damage, that in contrast to other agents, is predominately ignored by the global genome repair pathway of the nucleotide excision repair (NER)(2) system. The aim of this study was to determine the antitumor activity of irofulven when administered in combination with 44 different DNA damaging agents, whose damage is in general detected and repaired by the genome repair pathway... CONCLUSION: These results indicate that the antitumor activity of irofulven is enhanced when combined with platinum-derived agents, altretamine, and select alkylating agents such as melphalan or chlorambucil. A common factor between these agents appears to be the production of intrastrand DNA crosslinks. The synergistic interaction between irofulven and other agents may stem from the nucleotide excision repair system being selectively overwhelmed at two distinct points in the pathway, resulting in prolonged stalling of transcription forks, and subsequent initiation of apoptosis.

Long-term follow-up of a phase II trial of oral altretamine for consolidation of clinical complete remission in women with stage III epithelial ovarian cancer in the Southwest Oncology Group. [2004.03]
OBJECTIVE: This report provides follow-up progression-free survival (PFS) and median survival data for women who achieved clinical complete remission (cCR) from stage III ovarian cancer after first-line therapy and were treated with altretamine consolidation therapy... CONCLUSIONS: Consolidation therapy with oral altretamine was generally well tolerated and associated with prolonged progression-free and overall survival in the Phase II setting.

Oral altretamine used as salvage therapy in recurrent ovarian cancer. [2004.01]
CONCLUSION: Outpatient-administered oral altretamine can provide a prolonged disease-free interval with minimal toxicity.

Altretamine (hexamethylmelamine) in the treatment of platinum-resistant ovarian cancer: a phase II study. [2003.02]
OBJECTIVE: To evaluate the activity of oral Altretamine in women with epithelial ovarian carcinoma who responded (PR or CR) to first line chemotherapy but relapsed within 6 months. The protocol was later amended to include patients with relapse within 12 months... CONCLUSION: Altretamine should not be chosen as standard treatment in patients with platinum-resistant recurrent ovarian cancer. However, Altretamine represents a useful alternative in patients who prefer oral treatment or when socioeconomic considerations are an important issue.

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Clinical Trials Related to Hexalen (Altretamine)

Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors [Not yet recruiting]
This pilot phase Ib trial studies the side effects and best dose of recombinant EphB4-HSA fusion protein when given together with standard chemotherapy regimens in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic). Drugs used in chemotherapy, such as recombinant EphB4-HSA fusion protein, paclitaxel albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, docetaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether standard chemotherapy regimens are more effective with recombinant ephB4-HSA fusion protein in treating advanced or metastatic solid tumors.

Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors [Recruiting]
This study is about an experimental drug called sEphB4-HSA (recombinant albumin fusion protein sEphB4-HSA). This research study will be the first time sEphB4-HSA is given to people. sEphB4-HSA prevents tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. sEphB4-HSA has shrunk colon, lung, breast, glioma, melanoma, prostate and Kaposi's sarcoma tumors in mice

Effect of HSA or Saline Diluent on Immunotherapy Extract Stability as Determined by Graded ID Skin Tests [Recruiting]
This is a double-blind study with respect to the diluents used, with patients known to be allergic to the specific allergen tested. Three study sites will be involved, each testing one allergen (Cat, Mite, Timothy grass pollen). Subjects who are known to be allergic to the allergen in question will be tested with serial three-fold dilutions to determine the ID 50 and relative extract potency using the method described by Turkeltaub.

Phase I BP Interferon (IFN) Beta-004 [Completed]
Phase I study aiming at:

- establishing the pharmacokinetic profile of interferon beta-1a after i. v.

administration of the formulation BioPartners IFN beta-1a without albumin (HSA-free solution in pre-filled syringes) at 18 MIU;

- investigating the possible impact of albumin on pharmacokinetic profile by comparing 3

different i. v. formulations: BioPartners IFN beta-1a without albumin (HSA-free solution in pre-filled syringes), BioPartners IFN beta-1a with added albumin (HSA+), and Rebif® from Merck-Serono, a registered IFN beta-1a solution containing HSA;

- establishing the steady state pharmacokinetic profile of BioPartners IFN beta-1a in

HSA-free solution after 4 subsequent s. c. doses of 18 MIU given at 48 hour intervals against Rebif® using the same regimen.

Succinylated Human Serum Albumin (Suc-HSA) for HIV-1 Infection [Completed]

more trials >>


Page last updated: 2015-08-28

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